Kyowa Kirin is a global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four areas of unmet need: oncology, nephrology, immunology, and CNS/movement disorders. The North American organization includes two offices (in New Jersey and California) that focus on drug discovery, product development, and commercialization. Together, we work as a close-knit team to understand clinical needs and advance innovations that can profoundly impact patient lives.
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Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.
Summary:
The Manager, ICT Delivery plays a critical role in delivery of complex technology projects and IT services. They combine strategic planning with tactical execution to align team output with broader organizational goals, managing everything from initial scoping to final deployment and post-launch support. They ensure that digital initiatives are executed efficiently, securely and in alignment with GxP standards. They exhibit strong delivery leadership with a deep appreciation for the complexities of the pharmaceutical environment.
Essential Functions:
• Participate in project planning, execution, risk management, and quality assurance across multiple concurrent initiatives.
• Ensure solutions meet regulatory and data privacy requirements, including GxP, 21 CFR Part 11, HIPPA, GDPR and data integrity standards.
• Apply and follow appropriate delivery methodologies (Agile, Waterfall, hybrid) based on project needs and compliance considerations.
• Collaborate with business, technical teams and vendors to ensure accurate translation of business requirements into technical solutions.
• Assume accountability throughout all phases of system development lifecycle from ideation and planning through production support and troubleshooting.
Additional activities may include, but are not limited to:
• IT Project Oversight - Review project timelines, milestones, risks and budget to ensure delivery stays on track.
• Stakeholder Communication & Alignment - Manage expectations, clarify priorities and drive compromise between business needs and technical constraints.
• SDLC Compliance – Ensure all system changes follow appropriate lifecycle processes; review documentation for accuracy, completeness, and audit readiness.
• Issue Resolution & Operational Support – Assist in the triage of issues / incidents that impact production systems or project timelines.
Requirements:
Education
Bachelor’s degree or equivalent experience in computer science, information systems, engineering or related fields required
Experience
At least 5 years’ experience delivering IT projects within a regulated industry, ideally pharmaceuticals or life sciences; Familiarity with multiple functional domains (e.g. Quality, Regulatory, Medical, Commercial and/or Clinical); Knowledge of GxP compliance, validation practices and regulated system requirements; Experience with large-scale, global implementations; Experience with enterprise technologies such as Veeva Vault, Salesforce.com, Microsoft Dynamics
Technical Skills
Proficient in MS Office Suite.
Working Conditions:
Requires up to 10% domestic and international travel
The anticipated salary for this position will be $121,000 to $156,800. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
#LI-TT1 #Hybrid #Princeton
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Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.
Summary:
The Senior Manager, Supply Chain is responsible for leading Supply Chain at the Sanford Manufacturing Site. The Senior manager will ensure the reliable and efficient supply of clinical and commercial drug products to regional & global supply chains. This role is a key contributor to the planning team (locally, regionally and globally); supporting all aspects of materials management, product supply and inventory management, enabling the extraction of business insights from data, establishing and evaluating key performance indicators, and using continuous improvement methodologies to improve the overall process robustness of the supply chain. This role will be responsible for supporting the management of Drug Substance supply and inventory, associated activities within our ERP/MRP, demand, capacity, serialization, and inventory management systems (Plan/Source/Make/Deliver) and is a functional subject matter expert in the related processes. The Senior Manager, Supply Chain leads product operations including Warehouse and Distribution site operations using digital & team facilitation capabilities to ensure the reliable flow of products.
Essential Functions:
Represents the Sanford Manufacturing Site in the monthly demand/supply planning processes (S&OE, S&OP, etc).
• Develops and optimizes inventory strategies for KKNC products and owns business processes related to supply chain execution via ERP/MRP functionality.
• Responsible for master data management for direct materials, inclusive of Bill of Materials maintenance for existing & launch products.
• Assists in the facilitation of the Requisition to Pay processes related to ongoing management of the business
• Develop and govern the process through which production schedules are developed and managed within the value streams, including prioritization logic, constraint management, process controls, and flex/buffer strategies while achieving company revenue goals, customer service goals, inventory, and lean productivity goals
• Understand and highlight capacity constraints and work collaboratively with Manufacturing on resolution across resources and constraints.
• Develop and implement inventory management strategies that support supply plant health & resilience, minimize risk of E&O for both finished goods (manufactured drug substance) and raw materials, while balancing inventory and availability goals.
• Uses continuous improvement methodologies to evaluate process gaps, improve cross-functional performance, and elevate efficiency and efficacy.
• Develops SOPS, Work Instructions, and Job-Aids to ensure the robustness of planning execution and is the owner of supply chain maps. Leads project management activities for improvement initiatives / strategic initiatives.
• Supports the development and management of Sanford Manufacturing Site supply chain needs inclusive of logistics, warehousing, planning, digitization, and supports the annual strategy deployment process and while contributing to the growth of a high-performing team.
• Establishes, monitors, and improves business performance metrics and improvement targets to ensure best in class operations are realized
•Establishes change management plans inclusive of ERP update deployment, required testing, UAT’s and user adoption activity
Requirements:
Education
Bachelor’s Degree Required, with focus in Supply Chain Management, Industrial Engineering, or other business management subject area or related field.
Experience
5+ years direct Supply Chain Management / Operations experience ideally within Life Sciences manufacturing, or highly regulated industry, preferably within a manufacturing site environment.
Technical Skills
•Deep knowledge in planning processes: S&OP, New Product Introduction, Forecasting, Demand, Supply, Material & Inventory Planning
•Understanding of Manufacturing site Supply Chain operations, inclusive of Logistics, Packaging, Warehouse Management operations.
•High Level of Proficiency using and driving effectivity of ERP, such as SAP, JDE, Preferably MS D365
•Proficiency with planning and business insights tools (APO, Kinaxis, O9 Solutions), PowerBI, Qlikview, and legacy business management software (MS Office Suite)
•Knowledge of and capability to effectively use continuous improvement / process improvement methodologies and tools (such as LEAN Six Sigma, Toyota Production System)
Non-Technical Skills
•Results-oriented you set clear outcomes, track progress, follow through on commitments and ensure your actions lead to measurable results that advance organizational objectives.
•Solutions minded with strong critical thinking & analytical skills
•Strong Interpersonal & communication (verbal & written) skills are required.
•Risk/Resiliency Modeling & Contingency Planning experience is preferred
•Ability to thrive in a matrixed, diverse-culture environment
•Action-oriented and accountable, desiring results.
•Desires to be part of a High-Performing Team and to promote the development of High-Performing team members.
Physical Demands:
Initially working on a construction site and ultimately in a biotech manufacturing facility in Sanford, NC. Work is 100% on-site. This is not a hybrid or remote role.
Working Conditions:
Requires up to 10% domestic and international travel
The anticipated salary for this position will be $154,400 to $171,600. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
#LI-TT1 #On-Site #Sanford
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Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.
This territory cover - New York City, New Jersey, Delaware, Eastern Pennsylvania, Maryland, Virginia, Tennessee, Kentucky
Summary of Job:
The Regional Account Manager (RAM) – Rare Disease is a critical commercial role responsible for expanding the diagnosed patient population and driving appropriate treatment initiation through education-driven, data-informed field engagement. This role is designed to complement existing Regional Business Manager (RBM) coverage by placing primary emphasis on new and earlier patient identification, diagnostic pathway enablement, and referral network activation.
In rare disease markets, where growth is driven by patient identification rather than market share shifts, the Regional Account Manager focuses on uncovering diagnostic gaps, enabling earlier disease recognition, and ensuring appropriate handoff of qualified patient opportunities to RBMs for treatment initiation and account execution. The RAM serves as a field integrator across the local ecosystem and works in close collaboration with Regional Business Managers and relevant cross-functional partners
Essential Functions:
Patient Identification & Diagnostic Enablement
Territory Strategy & Data-Driven Execution
Cross-Functional Collaboration
Compliance & Professional Conduct
Success Metrics (KPIs)
Primary Metrics
Secondary Metrics
Job Requirements:
Education
Experience
Preferred Qualifications
Travel Requirements
Technical Skills
Non-Technical Skills
The anticipated salary for this position will be $185,500 to $202,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 212 Carnegie Center Dr. Suite 510 Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.
Recruitment & Staffing Agencies
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
#LI-PE1
#LI-Field
Ready to apply?
Apply to Kyowa Kirin North AmericaShare this job
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.
Summary of Job:
The Specialist II, Quality Control Microbiology plays a key role in establishing and executing microbiological testing activities within the QC organization at Kyowa Kirin’s new monoclonal antibody drug substance manufacturing facility in Sanford, NC. This position begins in a greenfield environment and evolves through GMP readiness, technology transfer, and facility licensure for Phase III and early commercial products.
You apply technical knowledge to routine and moderately complex microbiological tasks, collaborate across functions, and begin demonstrating independent problem-solving. Responsibilities include executing microbiological methods, maintaining compliance with current GxP standards, and ensuring alignment with global, regional, and site-specific procedures within Kyowa Kirin’s Quality Management System. This role is essential to building a reliable, compliant, and science-driven QC Microbiology function that supports the broader manufacturing and quality strategy.
As an individual contributor, you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment, always acting in line with the organization’s values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs. You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts.
Reporting Relationship: Senior Manager, Quality Control
Essential Functions:
Technical Skills, Knowledge, and Experience:
Subordinates: Individual Contributor with responsibility to lead or work with cross-functional project teams.
Job Requirements:
Education
Experience
Technical Skills
Non-Technical Skills
Physical Demands:
Initially this position requires working on a construction site and ultimately in a biotech manufacturing laboratory. Must be able to work in an office and regulated manufacturing environment, including construction/start-up phases. During the construction and start-up phases, employees may be required to wear appropriate personal protective equipment (PPE), including hard hats, safety glasses, steel-toe boots, and high-visibility vests. Once transitioned to the GMP laboratory environment, PPE will include lab coats, gloves, safety goggles, and other gear as defined by site safety protocols. This position is based on-site in Sanford, NC. Work is 100% on-site. Other standard company policies for flexible work arrangements do not apply to this role. This is not a hybrid or remote role.
Working Conditions: Requires up to 10% domestic and limited international travel. Travel to Japan may be required for training and qualification activities during technology transfer process.
The anticipated salary for this position will be $76,200 to $104,800. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
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Ready to apply?
Apply to Kyowa Kirin North AmericaShare this job
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.
As the Senior Maintenance and Utilities Technician, this role ensures the reliable operation and maintenance of facility utilities and equipment at our biopharmaceutical manufacturing site by applying advanced expertise in GMP, regulatory compliance, and technical troubleshooting. You manage complex projects, mentor other technicians, and implement best practices to enhance team performance and efficiency. By proactively addressing maintenance needs and minimizing downtime, you maintain a clean, safe, and compliant production environment.
As an individual contributor, you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment, always acting in line with the organization’s values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs. You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts.
This role reports into the Manager, Maintenance and Utilities
Technical Skills, Knowledge, and Experience
• Perform scheduled inspections, preventive maintenance, and corrective repairs on bioprocessing equipment such as bioreactors, centrifuges, and filtration units to ensure optimal performance and reliability.
• Execute preventive and corrective maintenance on facility utilities, including boilers, chillers, air compressors, WFI water systems, HVAC systems, and other critical infrastructure as required.
• Proactively diagnose complex equipment malfunctions, conduct timely repairs, and implement long-term solutions to prevent recurrence; escalate unresolved or critical issues to appropriate management or technical experts, providing clear documentation and recommendations.
• Demonstrate a strong commitment to safety by adhering to all Environmental, Health, and Safety (EHS) policies and proactively identifying and mitigating potential hazards.
• Provide technical support for the start-up, commissioning, and turnover of new systems throughout the site, ensuring seamless integration and compliance.
• Maintain accurate and comprehensive maintenance records in compliance with GMP (Good Manufacturing Practices), FDA regulations, and audit requirements.
• Collaborate closely with process engineers, quality assurance, manufacturing staff, and other cross-functional teams to resolve technical issues and support operational goals.
• Mentor and provide technical guidance to other technicians and contractors, fostering knowledge sharing and professional development.
• Document root causes of equipment failures and recommend effective, long-term solutions to enhance reliability and efficiency.
• Plan and execute site shutdowns effectively, ensuring minimal disruption to operations while maintaining safety, compliance, and schedule adherence.
Individual contributor, with responsibility to lead or work with cross-functional project teams.
Education/Experience
• High School Diploma with 3-5 years relevant experience.
Technical Skills
• Demonstrate proficiency in CMMS platforms such as D365 EAM, SAP PM, Maximo, or equivalent systems to manage calibration schedules, documentation, and asset history.
• Collaborate effectively with internal stakeholders and service partners to deliver high-quality, customer-focused calibration and maintenance solutions.
• Communicate clearly and professionally, both verbally and in writing, to ensure accurate documentation and effective coordination across teams.
• Apply strong organizational skills and attention to detail to maintain data integrity, ensure compliance, and achieve audit readiness.
• Demonstrated ability to develop, coordinate, and execute planned shutdowns, ensuring adherence to timelines, safety protocols, and operational requirements.
Non-Technical Skills
• Results-oriented and able to navigate ambiguity.
• Set clear outcomes, track progress, follow through on commitments, and ensure actions lead to measurable results that advance organizational objectives.
• Respond promptly, take accountability, and manage tasks efficiently.
• Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges.
• Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment.
• Communicate with care by actively listening and considering others' perspectives, fostering productive, engaging interactions, and managing relationships with kindness.
• Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset.
• Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment.
• Contribute positively by recognizing achievements and encouraging a healthy work-life balance.
• Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain.
• Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions.
• Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions.
Physical Demands:
Must be able to work in a regulated manufacturing environment, including construction/start-up phases, with appropriate PPE. Reasonable accommodation will be provided as required by law.
This position is based on-site in Sanford, NC. Other standard company policies for flexible work arrangements do not apply to this role. This is not a hybrid or remote role.
The anticipated salary for this position will be $35 to $48 per/hour. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
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Apply to Kyowa Kirin North AmericaShare this job
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.
The Quality Engineer, FUME Lead is a key individual contributor role with functional Quality authority leading and ensuring quality and compliance during the startup and operation of Kyowa Kirin’s Sanford, NC greenfield site. For this role, FUME refers to Facilities, Utilities, Maintenance, and Equipment, including associated instruments and asset lifecycle systems. This role is responsible for building, implementing, and sustaining Quality Engineering processes that enable GMP operations and long-term regulatory compliance and inspection readiness.
As a member of the Quality Systems & Compliance team, the Quality Engineer, FUME Lead will set direction, build structure, and ensure compliant implementation with decision-making authority for FUME-related quality strategy, standards, and risk acceptance across equipment, utilities, facilities, and DS manufacturing processes. This role serves as the primary Quality Engineering SME for FUME systems and is accountable for regulatory compliance, inspection readiness, and audit defense, including direct interaction with health authorities and ownership of FUME-related inspection responses and commitments. This role independently prepares, presents, and defends Quality Engineering approaches and evidence during regulatory inspections, internal audits, and external audits.
As an individual contributor, you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment, always acting in line with the organization’s values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs. You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts.
This position reports to the Sr. Manager, Quality Systems & Compliance.
Technical Skills, Knowledge, and Experience
• Act as the Quality Engineering lead for the Sanford site, owning priorities and outcomes and establish clear standards, workflows, and governance to ensure consistency and sustainability as the site grows.
• Lead and provide Quality oversight of GMP readiness activities for facility startup, including equipment, utilities, facilities, and process validation and documentation generation.
• Sustain compliance through lifecycle management of FUME systems, continuous improvement, and ongoing inspection readiness; confirm readiness of systems by reviewing evidence such as drawings, P&IDs, validation deliverables, and turnover packages to ensure fitness for intended use.
• Drive structured problem solving for issues related to equipment, utilities, facilities, instruments, PMs, and calibrations and contribute to the creation of the Preventative Maintenance (PM) and calibration programs, including review of plans, intervals, and criticality assessments.
• Execute and/or provide quality technical leadership of change controls and risk assessments (e.g., FMEA, hazard analysis), including defining risk strategy, ensuring appropriate mitigation, and approving risk acceptance decisions of FUME systems.
• Drive structure problem-solving for issues related to equipment, utilities, facilities, calibrations, and PMs and ensure all activities are consistent with data integrity expectations, Part 11 requirements, and ALCOA++ principles.
• Partner with Engineering, Validation, and Maintenance Teams to maintain inspection-ready documentation and asset status and work collaboratively across teams to support startup activities and ensure compliant execution.
• Review and approve work orders, CQV protocols and reports, change controls, deviations and CAPAs associated with FUME systems, and serve as the Quality lead for FUME related internal, external, and regulatory audits, including inspection preparation, execution, and follow-up.
Non-Technical Skills
Results-oriented and able to navigate ambiguity. Demonstrates the ability to set clear outcomes, track progress, follow through on commitments, and ensure your actions lead to measurable results that advance organizational objectives. Responds promptly, takes accountability, and manages tasks efficiently. Adapts to change with clarity, patience, and understanding while influencing peers and key stakeholders through evolving challenges. In this role, you will exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment. Communicate with care by actively listening and considering others' perspectives, fostering productive, engaging interactions, and managing relationships with kindness. Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset. Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment. Contribute positively by recognizing achievements and encouraging a healthy work-life balance. Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain. Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions. Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions.
Individual contributor, with responsibility to lead cross-functional project teams and provide Quality governance and influence decision making across FUME related initiatives.
Education
• Bachelor’s degree in engineering or science related field required.
• Master’s degree in engineering or science related field considered a plus.
Experience
• Minimum 8 plus years of direct industry experience in a GxP-regulated environment with a focus on Quality Engineering; including demonstrated experience serving as a Quality SME during regulatory inspections and/or audits.
• Demonstrated experience in qualification, validation, change control, and Quality Engineering activities.
• Direct experience with PM and Calibration systems, equipment lifecycle management, or CMMS platforms highly preferred
• Familiarity with DS single-use biologics operations or greenfield startup environments is preferred.
Must be able to work in an office and regulated manufacturing environment, including construction/start-up phases, with appropriate PPE. Reasonable accommodation will be provided as required by law.
This position is based on-site in Sanford, NC. Other standard company policies for flexible work arrangements do not apply to this role. This is not a hybrid or remote role.
This role may require travel up to 5% domestic and typically limited international travel.
The anticipated salary for this position will be $129,000 to $193,500. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
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Kyowa Kirin is a global specialty pharmaceutical company committed to improving the lives of patients. Kyowa Kirin, Inc., the U.S. operating entity, is expanding its North American footprint by building its first U.S. manufacturing facility in Sanford, North Carolina (“Sanford”), a greenfield site currently progressing through the construction phase. As the site moves toward start‑up and future operations, we are seeking a full‑time, embedded attorney to support this critical initiative as it scales from build‑out to steady‑state operations.
Summary of Job:
The Manufacturing Counsel will be a member of the U.S. Kyowa Kirin Legal Department and serve as the primary legal business partner supporting the Sanford manufacturing site, with a focus on contracting and transactional support, while acting as the first point of legal contact for site leadership on regulatory, Human Resources, and operational matters.
This role will provide day‑to‑day legal support—in close collaboration with Legal, Compliance, Quality, and other internal subject‑matter experts—across Sanford‑related contracting and selected regulatory and compliance matters, including activities related to planning, construction, qualification, validation, regulatory submissions, and manufacturing operations.
As an individual contributor, the Manufacturing Counsel will operate as a trusted legal advisor, applying sound judgment, practical risk assessment, and a collaborative, solutions‑oriented approach in a fast‑paced, scaling manufacturing environment.
Reporting relationship:
Senior Director, Senior Corporate Counsel (Princeton, NJ), with dotted-line reporting relationship to the Vice President of Manufacturing (Sanford, NC).
Essential Functions:
Contracting & Transactional Support (primary responsibility)
• Utilize the Legal Department’s contract management system to manage the contracting process for Sanford-related agreements, including review, negotiation, approval, and execution.
• Partner with Sanford stakeholders to support the drafting and negotiation of manufacturing, construction, consulting, equipment, supply, and operations related agreements.
• Prepare guidance and training materials to support the efficient and compliant use of the Legal Department’s contract management system.
• Coordinate the work of paralegals and outside counsel supporting Sanford matters, as needed.
Regulatory & Human Resources Support
• Provide practical legal guidance on laws and regulations applicable to pharmaceutical manufacturing operations, including the Food, Drug, and Cosmetic Act. Partner with Princeton-based Legal colleagues and outside counsel, as needed, to address more complex or significant legal matters affecting Sanford operations.
• Provide legal support to Human Resources on Sanford-related employment and employee relations matters, in coordination with internal employment counsel and external counsel as appropriate.
• Work closely with colleagues from Legal and Compliance to provide consistent and efficient guidance in accordance with Kyowa Kirin’s healthcare compliance policies and related laws and regulations.
• Conduct legal research and draft memoranda / provide counsel in response to Sanford-related legal and regulatory inquiries.
Site Leadership & Strategic Cross-Functional Support
• Serve as a member of the Sanford site Senior Leadership Team and an embedded legal advisor to Sanford business partners by applying sound judgment, practical risk assessment, and a solutions‑oriented approach in a fast‑paced manufacturing and site‑startup environment.
• Engage regularly with Sanford site leadership and cross‑functional stakeholders to support alignment on contracting priorities, legal risk considerations, and compliance expectations.
• Collaborate with internal functions to support cross‑functional and cross‑border Sanford initiatives.
• Support Sanford‑related projects and initiatives that require coordination across functions or regions to ensure alignment with Kyowa Kirin policies and Legal Department practices.
• Develop strong working relationships across the organization and operate in alignment with Kyowa Kirin’s global values: Commitment to Life; Innovation; Integrity; and Teamwork / Wa.
Job Requirements:
Education
• BA/BS required.
• Juris Doctorate degree from Accredited Law School is required.
• Admission in good standing to at least one U.S. state bar; eligibility for North Carolina in-house registration required.
Experience
• 4–8 years of legal experience, preferably including contracting and legal support for manufacturing, construction, or operations in a regulated industry. Life science experience preferred but not required.
• Law firm experience required. In-house experience is a plus.
• Experience with cross-functional teams (including ex-US) and demonstrated ability to collaborate effectively with others to address complex legal, compliance, and operational issues is a plus.
• Experience in drafting and negotiating contracts such as master services agreements, statements of work, confidentiality agreements, consulting agreements, master purchase agreements, supply agreements, quality/technical agreements, and other corporate pharmaceutical-related and/or manufacturing-related agreements is required.
• Experience using contracting management systems (e.g., intake, workflow, approvals, and execution) is a plus.
• Must understand contract law and have effective communication and negotiation skills and the ability to influence and work collaboratively at all levels and across functions.
• Demonstrated understanding of pharmaceutical manufacturing operations and the related regulatory environment is a plus.
• Foundational understanding of employment law or counsel human resources functions is a plus.
• Experience supporting a start‑up, greenfield, or rapidly scaling operational environment is a plus.
Technical Skills
Advanced proficiency in MS Office Suite (Word, Excel, Outlook).
Non-Technical Skills
Results-oriented and able to navigate ambiguity, you set clear outcomes, track progress, follow through on commitments, and ensure your actions lead to measurable results that advance organizational objectives.
Comfortable working onsite in a manufacturing and construction environment and engaging directly with operational stakeholders.
Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment.
Communicate with care by actively listening and considering others' perspectives, fostering productive, engaging interactions, and managing relationships with kindness.
Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain.
Physical Demands: The role will initially involve work in an office setting and on an active construction site in Sanford, North Carolina, with a planned transition in 2027 to the fully operational Sanford manufacturing facility.
Working Conditions: Requires up to 10% domestic and limited international travel
The anticipated salary for this position will be $227,300 to $270,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
#LI-JC1
Ready to apply?
Apply to Kyowa Kirin North AmericaShare this job
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.
Summary of Job
The Senior MSAT Engineer will play a critical role in providing technical leadership for the technical transfer, manufacturing, and testing of clinical and commercial drug substances. The position requires a deep understanding of monoclonal Antibody (mAb) manufacturing processes and bioanalytical assays to ensure monitoring, troubleshooting and continuous improvement at the new Kyowa Kirin North America mAb drug substance manufacturing facility in Sanford, NC.
This role plays a critical role in facilitating the transfer of clinical and commercial drug substance manufacturing from other Kyowa Kirin sites or CMOs. Collaborating with internal and external teams, this role will drive the development of robust manufacturing processes and ensure seamless technology transfers. With deep expertise in mAb drug substance manufacturing and analytical methods, the Senior MSAT Engineer will lead transfer efforts for both new and existing products, ensuring efficiency, compliance, and operational readiness.
As an individual contributor, you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment, always acting in line with the organization’s values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs. You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts.
Essential Functions:
Education
Experience
Process and analytical skills
Non-Technical Skills
Results-oriented and able to navigate ambiguity, you set clear outcomes, track progress, follow through on commitments, and ensure your actions lead to measurable results that advance organizational objectives. Respond promptly, take accountability, and manage tasks efficiently. Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges. Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment. Communicate with care by actively listening and considering others' perspectives, fostering productive, engaging interactions, and managing relationships with kindness. Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset. Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment. Contribute positively by recognizing achievements and encouraging a healthy work-life balance. Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain. Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions. Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions.
Initially working on a construction site and ultimately in a biotech manufacturing site in Sanford, NC.
Work is 100% on-site. This is not a hybrid or remote role.
Working Conditions: Requires up to 50% domestic and international travel,
The anticipated salary for this position will be $135,000 to $155,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
#LI-PE1
Ready to apply?
Apply to Kyowa Kirin North AmericaShare this job
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.
The Calibration Technician is responsible for performing, coordinating, and documenting the calibration, maintenance, and repair of instrumentation and equipment in a regulated biopharmaceutical environment. This role ensures compliance with GxP and company quality standards while supporting production, laboratory, and facilities operations. The calibration technician will actively contribute to continuous improvement and team efficiency.
As an individual contributor, you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment, always acting in line with the organization’s values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs. You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts.
Essential Functions:
Technical Skills, Knowledge, and Experience
• Perform scheduled calibrations, adjustments, and preventive maintenance on laboratory, process, and facility instrumentation including pressure, temperature, flow, pH, conductivity, balances, HPLC, incubators, autoclaves, and cleanroom monitoring systems.
• Diagnose and resolve (with some assistance) complex instrumentation and equipment issues independently to minimize downtime and maintain operational continuity.
• Escalate unresolved, critical, or systemic calibration and instrumentation issues to the Supervisor, CMMS and Calibration Services, providing clear documentation and recommended actions.
• Develop and execute calibration procedures and protocols in compliance with GMP, ISO, and company standards; recommend updates based on technical findings and regulatory changes.
• Document all calibration activities, maintenance, and repairs accurately in CMMS/Calibration Management Systems to ensure traceability and audit readiness.
• Prepare documentation that meets GMP, FDA, and internal quality standards for inspections and audits; identify and correct gaps in compliance records.
• Assist in root cause analysis and implement corrective and preventive actions (CAPA) for calibration-related deviations.
• Collaborate with process engineers, manufacturing, quality assurance, and facilities teams to resolve technical issues and align on operational priorities.
• Communicate clearly and professionally with internal stakeholders to share updates, findings, and recommendations.
• Prioritize and manage multiple tasks and projects independently in a fast-paced, regulated environment while meeting deadlines and quality expectations.
• Promote a culture of safety, inclusion, and continuous improvement across calibration and maintenance activities.
Requirements:
Education
• High school diploma or equivalent, plus 1-3 years of relevant experience in calibration and/or instrumentation.
• Associate or bachelor’s degree in a related field (such as engineering technology, instrumentation, or life sciences), plus 1–2 years of relevant experience in calibration and/or instrumentation.
Experience
• Minimum of 1-3 years of demonstrated hands-on experience performing cGMP-compliant calibration in manufacturing, laboratory, or facility environments.
• Alternatively, demonstrated minimum of 2-4 years of calibration experience within a highly regulated industry (such as pharmaceuticals, medical devices, or aerospace) if direct GMP experience is not available.
Technical Skills
• Proficient in using CMMS platforms such as D365 EAM, SAP PM, Maximo, or similar systems to manage calibration schedules, documentation, and asset history.
• Demonstrated ability to collaborate effectively with internal teams and external clients, consistently promoting excellence in customer service and operational support.
• Exceptional communication and organizational skills, enabling clear information sharing and efficient workflow management across cross-functional teams.
• Meticulous attention to detail and a strong commitment to data integrity, ensuring all calibration records and documentation are accurate, complete, and audit-ready.
Non-Technical Skills
• Results-oriented and able to navigate ambiguity.
• Set clear outcomes, track progress, follow through on commitments, and ensure actions lead to measurable results that advance organizational objectives.
• Respond promptly, take accountability, and manage tasks efficiently.
• Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges.
• Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment.
• Communicate with care by actively listening and considering others' perspectives, fostering productive, engaging interactions, and managing relationships with kindness.
• Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset.
• Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment.
• Contribute positively by recognizing achievements and encouraging a healthy work-life balance.
• Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain.
• Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions.
• Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions.
Physical Demands/Working Conditions:
Must be able to work in a regulated manufacturing environment, including construction/start-up phases, with appropriate PPE. Reasonable accommodation will be provided as required by law.
This position is based on-site in Sanford, NC. Other standard company policies for flexible work arrangements do not apply to this role. This is not a hybrid or remote role.
• Requires up to 5% domestic travel, based on business need.
• Standard work schedule is Monday through Friday, 8:00 A.M. to 4:30 P.M.
• Position may transition to a 2-2-3 (EOW-Every Other Weekend) schedule format as the business needs change.
• This position is considered essential to the facility.
• On-call availability may be required to support urgent operational needs.
• Must be able to safely lift up to 50 lbs unassisted and perform tasks involving physical activity.
• Regular exposure to machinery, noise, and physical hazards in a manufacturing environment; appropriate personal protective equipment (PPE) is provided and required at all times.
• Work is performed 100% on-site at the Sanford, NC facility; remote or hybrid work is not available for this role.
The anticipated salary for this position will be $53,800 to $70,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
Ready to apply?
Apply to Kyowa Kirin North AmericaShare this job
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.
*** this territory will cover: Bloomington, Ft. Wayne, Hammond, Indianapolis, Peoria, South Bend, Springfield
Summary of Job:
The Regional Business Manager is a critical role in establishing KKI as a leader in Rare Diseases by demonstrating our commitment to supporting the efforts of Rare Disease healthcare providers in improving patient health outcomes and becoming a trusted resource in demonstrating value along the patient journey.
The Regional Business Manager will understand education referral networks to identify appropriate patients and ensure maintenance on Crysvita by supporting appropriate multidisciplinary support of the patients via their care network.
They will also work closely with the cross-functional teams at KKI.
The Regional Business Manager serves as the lead point of contact for activities within the assigned hospital networks, academic Institutions, and surrounding practices and works closely with Market Access, Sales, Marketing, and Medical Affairs.
Essential Functions:
Compliant
Job Requirements:
Education
Experience
Preferred:
Travel Requirements:
Technical Skills
Non-Technical Skills
The anticipated salary for this position will be $180,500 to $202,400. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 212 Carnegie Center Dr. Suite 510 Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.
Recruitment & Staffing Agencies
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
#LI-PE1
#LI-Field
Ready to apply?
Apply to Kyowa Kirin North AmericaShare this job
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.
Summary:
The Director of Pharmacometrics will lead a team of Pharmacometricians within the Global Development Organization (GDO) and Clinical Pharmacology (CP) function. The role is intended to have a balance of direct project related activities and to support team members in the development and execution of model informed drug development (MIDD) strategies. The Director of Pharmacometrics will support continued development of appropriate workflows and systems to provide quantitative clinical pharmacology deliverables. The Director of Pharmacometrics will help develop all GDO CP members on communication of MIDD strategies and approaches to project teams. The Director of Pharmacometrics will serve to communicate with and educate leadership across the GDO organization, including those in other GDO Functions, on the value of MIDD and quantitative clinical pharmacology strategies. The Director of Pharmacometrics will also look for innovative ways to work with Kyowa Kirin organizations outside of GDO, including but not limited to Regulatory Affairs and Medical Affairs, to increase MIDD strategies throughout development and in post-marketing space.
Essential Functions:
• Accountable for pharmacometrics deliverables supporting project teams, ensuring scientific quality, timeliness, and impact; identify and drive opportunities to advance quantitative clinical pharmacology across the organization.
• Guide pharmacometrics strategy and ensure high-quality preparation of pharmacometric components for scientific reports, regulatory submissions, and responses to health authority inquiries.
• Provide scientific and technical leadership to pharmacometrics staff, ensuring excellence in modeling approaches and effective communication at all organizational levels.
• Support clear and impactful communication of pharmacometric and clinical pharmacology results to diverse internal and external audiences.
• Collaborate with GDO Clinical Pharmacology colleagues and cross-functional partners to improve efficiency, alignment, and innovation across drug development initiatives.
• Advance Model-Informed Drug Development (MIDD) standards by incorporating best practices from the scientific community to continuously improve workflows, processes, and analytical rigor.
• Establish and implement workflows, tools, and training programs, leveraging internal and external resources to strengthen pharmacometrics capabilities within GDO Clinical Pharmacology, with particular focus on developing Pharmacometrics Leads.
• Develop and maintain a network of preferred external pharmacometrics experts to support advanced or specialized analyses as needed.
• Promote scientific visibility through conference presentations and peer-reviewed publications, ensuring dissemination of insights and research outcomes to the broader scientific community.
Requirements:
Education
PhD preferred with specialty training in Pharmacometrics, appropriate MS or PharmD also applicable
Experience
• Minimum 10 years of pharmaceutical industry experience gained in pharmacometrics / quantitative clinical pharmacology is required.
• The understanding and ability to communicate and apply MIDD strategies to drug development.
• Understanding of pharmacometrics contributions for successful clinical development of small molecules, biologics, and alternative therapies.
• Experience in the successful use of MIDD to support drug development decision making
• Ability to conduct hands-on modeling and simulation using appropriate quantitative tools in a regulated drug development environment, considered expert in field
• Experience in the preparation of strategic regulatory documents including reports, summary documents, and response to information requests.
• Leadership of a team with various backgrounds and skills in pharmacometrics.
• Experience of developing individuals pharmacometric and communication skills and talents
Technical Skills
Proficient in MS Office Suite.
Demonstrated proficiency with pharmacometric software tools for non-linear mixed effects modeling, data manipulation, physiologically based pharmacology, and systems pharmacology modeling, such as: Julia/Pumas app, R-studio, NONMEM.
The anticipated salary for this position will be $230,000 to $250,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
#LI-TT1 #Hybrid #Princeton
Ready to apply?
Apply to Kyowa Kirin North AmericaShare this job
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.
Summary:
The Associate Director, Site Budget Management provides strategic and operational leadership across assigned segments of Kyowa Kirin’s global clinical study portfolio. This role bridges study-level execution and enterprise strategy by overseeing budget governance, forecasting methodology, financial risk management, and process optimization initiatives.
The Associate Director drives consistency in budget development, negotiation parameters, and payment oversight while contributing to short and mid-range portfolio planning. This position ensures financial integrity, scalability, and alignment with global FMV standards across all new and ongoing studies within scope.
Essential Functions:
Portfolio Oversight and Financial Planning
• Provide oversight across multiple global studies within assigned therapeutic areas or portfolio segments.
• Partner with the Director to support long range financial planning across the clinical pipeline.
• Review and validate study-level forecasts to ensure portfolio alignment.
• Identify cross-study cost trends, variance drivers, and financial risk indicators.
• Support accrual accuracy and forecast predictability.
Global Budget Governance and FMV Oversight
• Ensure consistent application of FMV methodology across assigned studies.
• Validate high, mid, and low negotiation parameters.
• Review CRO-developed budgets for compliance and alignment to governance standards.
• Support regional alignment including US, EU, and Japan point system methodologies.
• Maintain audit-ready documentation and financial traceability.
Budget Development and Negotiation Leadership
• Oversee study-level budget build, review, and approval processes.
• Provide negotiation strategy guidance to Senior Managers and CRO analysts.
• Escalate deviations outside approved financial thresholds.
• Ensure budget alignment with protocol scope and operational effort.
• Review amendment-related financial impacts.
Process Optimization and Standardization
• Identify opportunities to improve global budget workflows.
• Standardize templates, parameter frameworks, and tracking tools.
• Reduce negotiation cycle times through structured governance.
• Contribute to automation and systems integration initiatives.
• Develop KPIs to measure performance, cycle time, and cost containment.
Site Payment and Vendor Oversight
• Provide financial oversight of site payment execution across assigned portfolio.
• Monitor vendor and CRO payment performance.
• Review reconciliation reporting and identify discrepancies.
• Serve as escalation point for complex payment-related issues.
• Ensure payment schedules align with approved budgets and contractual terms.
Financial Analytics and Executive Reporting
• Prepare consolidated financial dashboards for assigned portfolio segment.
• Provide variance analysis and risk summaries.
• Support executive reporting with clear financial narratives.
• Conduct scenario modeling to evaluate financial impact of amendments, enrollment changes, or country mix adjustments.
Leadership and Organizational Support
• Directly manage Site Budget Managers and Senior Managers as assigned.
• Provide strategic oversight to CRO budget analysts within outsourced model.
• Mentor team members on forecasting discipline and governance expectations.
• Support resource demand planning based on study complexity and portfolio growth.
Requirements:
Education
Bachelor’s degree in finance, Business Administration, Accounting, Life Sciences, or related discipline required.
Advanced degree or professional certification preferred
Experience
• Minimum seven (7) years of experience in clinical trial budgeting, site financial management, or global clinical business operations.
• Demonstrated experience managing global site budgets.
• Experience within an outsourced CRO operating model.
• Experience supporting portfolio forecasting and financial analytics.
• Experience leading or mentoring budget professionals.
• Working knowledge of Japan FMV methodology preferred.
Technical Skills
• Advanced Excel and financial modeling capability.
• Expertise in FMV benchmarking tools.
• Experience with GrantPlan or equivalent systems.
• Familiarity with CTMS, reporting platforms, and payment tracking systems.
• Strong analytical and risk assessment capability.
Core Competencies
• Strategic thinking with operational execution strength
• Financial governance discipline
• Process improvement mindset
• Executive communication capability
• Risk identification and mitigation
• Structured decision making
• Cross-functional collaboration
• High integrity and compliance orientation
Working Conditions:
• Requires up to 10%-15% domestic and international travel
• Availability to support global teams across multiple time zones, including periodic late evening calls.
The anticipated salary for this position will be $175,000 to $205,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
#LI-TT1 #Remote #Princeton
Ready to apply?
Apply to Kyowa Kirin North AmericaShare this job
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.
Ideal candidates would like near a major airport.
Northwest –
Job Summary:
The Field Reimbursement Manager is a regionally field based position that provides reimbursement and access support for patients who have been prescribed a rare disease product. Reporting to the Director, Patient Access Solutions, he/she will work closely with physicians, nurses, pharmacists, and ancillary staff, as well as patients and caregivers of patients to prevent and address barriers to patient access and reimbursement. Also, this candidate will align with Kyowa Kirin’s Commercial and Patient Services Team(s), to ensure that the team is collaborating on behalf of patients, their care teams, and other therapy partners to ensure access to uninterrupted therapy and support throughout the patient treatment journey.
Essential Functions:
Job Requirements:
Education
Bachelor’s Degree or equivalent experience required
Experience
A minimum of 5+ years of experience in a Market Access and/or Patient Services role, with extensive prior knowledge in patient access and reimbursement required
Technical Skills
Proficient in MS Office Suite
Non-Technical Skills
Physical Demands:
Field based/Normal office environment with prolonged sitting and extensive computer work
Working Conditions:
Requires up to 80% domestic and international travel
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 135 Route 202/206, Suite 6, Bedminster, NJ 07921 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.
Recruitment & Staffing Agencies
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
Annualized base salary ranges from $150,000 – $185,000 plus sales incentive; actual salaries will vary and may be above or below this range commensurate with various factors including but not limited to experience, education, training, and merit.
This position is eligible for a company car through the Company’s FLEET program.
Kyowa Kirin provides a comprehensive compensation and benefits package which includes:
#LI-PE1
#LI-Field
Ready to apply?
Apply to Kyowa Kirin North AmericaShare this job
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.
Ideal candidates would like near a major airport.
Central East –
Job Summary:
The Field Reimbursement Manager is a regionally field based position that provides reimbursement and access support for patients who have been prescribed a rare disease product. Reporting to the Director, Patient Access Solutions, he/she will work closely with physicians, nurses, pharmacists, and ancillary staff, as well as patients and caregivers of patients to prevent and address barriers to patient access and reimbursement. Also, this candidate will align with Kyowa Kirin’s Commercial and Patient Services Team(s), to ensure that the team is collaborating on behalf of patients, their care teams, and other therapy partners to ensure access to uninterrupted therapy and support throughout the patient treatment journey.
Essential Functions:
Job Requirements:
Education
Bachelor’s Degree or equivalent experience required
Experience
A minimum of 5+ years of experience in a Market Access and/or Patient Services role, with extensive prior knowledge in patient access and reimbursement required
Technical Skills
Proficient in MS Office Suite
Non-Technical Skills
Physical Demands:
Field based/Normal office environment with prolonged sitting and extensive computer work
Working Conditions:
Requires up to 80% domestic and international travel
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 135 Route 202/206, Suite 6, Bedminster, NJ 07921 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.
Recruitment & Staffing Agencies
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
Annualized base salary ranges from $160,000 – $185,000 plus sales incentive; actual salaries will vary and may be above or below this range commensurate with various factors including but not limited to experience, education, training, and merit.
This position is eligible for a company car through the Company’s FLEET program.
Kyowa Kirin provides a comprehensive compensation and benefits package which includes:
#LI-PE1
#LI-Field
Ready to apply?
Apply to Kyowa Kirin North AmericaShare this job
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.
The Sr. Manager, CQV will be responsible for leading and overseeing all commissioning, qualification, and validation activities for facilities, utilities, equipment, and computerized systems supporting pharmaceutical manufacturing operations. This role ensures compliance with FDA, EMA, and global regulatory requirements, including GMP, GAMP 5, 21 CFR Part 11, and Annex 11, while supporting project delivery, operational readiness, and continuous improvement.
This role reports into the Director of Engineering
Technical Skills, Knowledge, and Experience
This role provides strategic direction, manages internal and external resources, and partners cross functionally to ensure validation activities are executed efficiently, compliantly, and aligned with business objectives. Experience using Valgenesis is a plus.
Leadership & Management
• Lead, mentor, and develop a team of CQV and CSV engineers and specialists.
• Establish departmental goals, performance metrics, and development plans.
• Manage external consultants and validation service providers.
• Serve as a subject matter expert (SME) for CQV/CSV across the organization.
Commissioning & Qualification (CQ)
• Develop and implement commissioning and qualification strategies for:
o Manufacturing equipment
o Process equipment
o Facilities and cleanrooms
o Critical utilities (HVAC, WFI, compressed gases, etc.)
• Oversee execution of DQ, IQ, OQ, PQ activities.
• Ensure traceability to user requirements and regulatory expectations.
• Support startup, tech transfer, and commercial readiness activities.
Computer System Validation (CSV)
• Lead validation of computerized systems including:
o Manufacturing Execution Systems (MES)
o Laboratory systems (LIMS, CDS)
o Quality systems (QMS, eDMS)
o Automation and control systems (PLC, SCADA, DCS)
• Ensure compliance with GAMP 5, 21 CFR Part 11, and EU Annex 11
• Approve validation plans, risk assessments, protocols, and final reports.
• Oversee data integrity assessments and periodic reviews.
Compliance & Quality
• Ensure validation lifecycle documentation meets regulatory and internal quality standards.
• Support regulatory inspections and audits (FDA, EMA, MHRA, etc.)
• Address audit observations, deviations, CAPAs, and change controls related to validation.
• Drive risk based validation approaches and continuous improvement initiatives.
Project & Stakeholder Management
• Partner with Engineering, IT, Quality, Manufacturing, and Automation teams
• Support capital projects, expansions, and new product introductions.
• Manage validation timelines, budgets, and resource planning.
• Provide clear communication and reporting to senior leadership.
This role is a Manager of People
Education and Experience
• The following combination of education and professional experience is required for this role:
o Bachelor’s degree in a technical field required. Formal GMP and Safety training is essential.
o At least 7 years of management / 8 years of senior management experience in pharmaceutical, biotech, or regulated manufacturing environments. Experience with Tech Transfer is a plus.
Technical Skills
• Proficient in MS Office Suite
• Knowledgeable in cGMPs, GAMP, Safety Practices, Regulatory Compliance, Protocol Development and Execution, Risk Assessment, Criticality Assessment and System Turnover/Training.
Non-Technical Skills
Results-oriented and able to navigate ambiguity, you set clear outcomes, track progress, follow through on commitments, and ensure your actions lead to measurable results that advance organizational objectives. Respond promptly, take accountability, and manage tasks efficiently. Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges. Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment. Communicate with care by actively listening and considering others' perspectives, fostering productive, engaging interactions, and managing relationships with kindness. Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset. Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment. Contribute positively by recognizing achievements and encouraging a healthy work-life balance. Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain. Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions. Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions.
Initially, position requires working on a construction site and will ultimately transition to the biotech manufacturing site in Sanford, NC.
Work is 100% on-site. This is not a hybrid or remote role.
May require up to 10% domestic and limited international travel
The anticipated salary for this position will be $137,300 to $206,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
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Ready to apply?
Apply to Kyowa Kirin North AmericaShare this job
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.
The Quality Assurance Specialist Operations II plays a pivotal role in the launch and ongoing operations of the Quality Assurance organization at Kyowa Kirin’s new monoclonal antibody drug substance manufacturing facility in Sanford, NC. Starting in a greenfield environment, you will help establish QA systems and processes, then transition into providing technical leadership through GMP readiness, technology transfer, and facility licensure for late clinical and commercial products.
You will ensure that all GxP areas within the Site Operations maintain full compliance with current GxP standards and all applicable global, regional, and site procedures within Kyowa Kirin’s Quality Management System. This role offers a unique opportunity to shape a culture of quality from the ground up while contributing to the delivery of life-changing therapies.
Key responsibilities include executing core QA activities such as batch record review, Manufacturing Quality Assurance, QA oversight of warehouse, and incoming quality. You will collaborate cross-functionally to monitor site quality metrics, investigate deviations, and support continuous improvement initiatives. Leveraging the Global Quality Management System, you will ensure alignment with regulatory requirements, including data integrity standards. Through active participation in regulatory inspections and leadership in quality culture initiatives, you will help ensure the site operates with excellence, integrity, and accountability.
This role reports into the Senior Manager, Quality Assurance
Technical Skills, Knowledge, and Experience
• Apply advanced Quality Assurance expertise across GxP operations to support compliant manufacturing and ensure production goals are met.
• Perform as Shop Floor QA / Manufacturing QA with presence on the manufacturing floor; able to stand for 3 or more hours.
• Independently execute batch record review and approval, participate in Gemba walks, coordinate alarm responses, and conduct logbook audits to uphold operational integrity and regulatory compliance.
• Participate in batch disposition and support final product release by verifying documentation and quality standards to enable timely and compliant delivery.
• Support Warehouse and Incoming Quality activities by ensuring materials meet defined specifications and quality requirements.
• Review and approve Change Controls, CAPAs, and Deviations in Veeva to ensure timely execution and alignment with regulatory and quality standards.
• Identify and escalate discrepancies or non-compliant entries within the Quality Management System (Veeva), collaborating with process owners to resolve issues and ensure records meet regulatory and internal standards.
• Lead investigations of non-conformances, deviations, laboratory exceptions, and other cGMP issues; initiate CAPAs and communicate resolution plans to drive effective compliance.
• Monitor and analyze site quality metrics—including Deviations, CAPAs, Change Controls, Equipment Failures, EM data trends, and Product Disposition Cycle-times to identify trends, support continuous improvement, and ensure compliance.
• Review and approve procedures within Veeva, leveraging the global, regional, and local SOPs to ensure consistency and regulatory alignment.
• Champion a culture of quality in all GxP areas within the Site Operations by providing subject matter expertise focused on patient-centric practices, sustainable compliance, and inspection readiness.
• Participate in regulatory inspections by demonstrating site compliance and contributing to Quality Assurance activities.
• Develop, monitor, and communicate progress against goals across functions, to the Site Leadership Team, and to key stakeholders to ensure alignment and accountability.
• Ensure compliance with current regulatory requirements for Data Integrity (ALCOA+) as applicable to paper and electronic records, including 21 CFR Part 11.
Individual contributor, with responsibility to lead or work with cross-functional project teams.
Education
• Bachelor’s degree in a technical or scientific discipline (e.g., Chemical Engineering, Chemistry, Biology, or related field) preferred, with a minimum of 2 years relevant experience in biopharmaceutical manufacturing also preferred.
• Associate degree in a technical field and a minimum of 3 years of relevant experience in biopharmaceutical manufacturing.
• High school diploma or equivalent and a minimum 4 years of relevant experience in biopharmaceutical manufacturing.
• Experience with start-up and operation of biopharmaceutical manufacturing processes is a plus.
Experience
• At least 2 years of experience in a GxP regulated environment, with a focus on batch record review, batch disposition, Shop Floor QA, Manufacturing Quality Assurance, and/or Incoming Quality Assurance.
• Performed QA batch disposition and final product release by verifying documentation accuracy and ensuring alignment with regulatory standards.
• Reviewed and approved batch records, conducted Gemba walks, responded to alarms, and audited logbooks to maintain operational integrity and ensure compliance.
• Reviewed and approved Change Controls, CAPAs, and/or Deviations, ensuring timely resolution and alignment with quality and regulatory expectations.
• Performed investigations of non-conformances, deviations, and laboratory exceptions; initiated and followed through on CAPAs to ensure effective resolution.
• Participated in regulatory inspections by demonstrating site compliance and executing QA activities aligned with inspection-readiness standards.
• Experience using an Electronic Document Management System in the area of Document Management, Deviation, CAPA, Training, and/or Change Control.
• Executed daily QA operations at the manufacturing site while collaborating cross-functionally to drive compliance and continuous improvement.
Technical Skills
• Proficient in MS Office Suite.
• Proficient in using an Electronic Document Management System for documentation, workflow management, and compliance tracking.
Non-Technical Skills
• Results-oriented and able to navigate ambiguity.
• Ability to stand for 3 or more hours while on the shop floor.
• Ability to work a 2-2-3 schedule where each shift is 12 hours in length. During construction and commissioning, this position will follow a Monday–Friday day shift schedule. Once the facility is operational, the role will transition to a 2-2-3 day shift (7:00 AM – 7:00 PM). Shift flexibility may be required during production runs.
• Set clear outcomes, track progress, follow through on commitments, and ensure actions lead to measurable results that advance organizational objectives
• Respond promptly, take accountability, and manage tasks efficiently.
• Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges.
• Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment.
• Communicate with care by actively listening and considering others' perspectives, fostering productive, engaging interactions, and managing relationships with kindness.
• Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset.
• Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment.
• Contribute positively by recognizing achievements and encouraging a healthy work-life balance.
• Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain.
• Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions.
• Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions.
Must be able to work in an office and regulated manufacturing environment, including construction/start-up phases, with appropriate PPE. Reasonable accommodation will be provided as required by law.
This position is based on-site in Sanford, NC. Other standard company policies for flexible work arrangements do not apply to this role. This is not a hybrid or remote role.
This position is an on-site and on the manufacturing floor
The anticipated salary for this position will be $40.48 per/hr to $49.47 per/hr. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
#LI-JC1
Ready to apply?
Apply to Kyowa Kirin North AmericaShare this job
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.
This territory cover - : Illinois, Minnesota, Michigan, Wisconsin, Indiana, Iowa, Colorado, Utah, and Nevada
Summary of Job:
The Regional Account Manager (RAM) – Rare Disease is a critical commercial role responsible for expanding the diagnosed patient population and driving appropriate treatment initiation through education-driven, data-informed field engagement. This role is designed to complement existing Regional Business Manager (RBM) coverage by placing primary emphasis on new and earlier patient identification, diagnostic pathway enablement, and referral network activation.
In rare disease markets, where growth is driven by patient identification rather than market share shifts, the Regional Account Manager focuses on uncovering diagnostic gaps, enabling earlier disease recognition, and ensuring appropriate handoff of qualified patient opportunities to RBMs for treatment initiation and account execution. The RAM serves as a field integrator across the local ecosystem and works in close collaboration with Regional Business Managers and relevant cross-functional partners
Essential Functions:
Patient Identification & Diagnostic Enablement
Territory Strategy & Data-Driven Execution
Cross-Functional Collaboration
Compliance & Professional Conduct
Success Metrics (KPIs)
Primary Metrics
Secondary Metrics
Job Requirements:
Education
Experience
Preferred Qualifications
Travel Requirements
Technical Skills
Non-Technical Skills
The anticipated salary for this position will be $185,500 to $202,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 212 Carnegie Center Dr. Suite 510 Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.
Recruitment & Staffing Agencies
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
#LI-PE1
#LI-Field
Ready to apply?
Apply to Kyowa Kirin North AmericaShare this job
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.
This territory cover - Massachusetts, Connecticut, Rhode Island, Maine, New Hampshire, Vermont, Central & Western Pennsylvania, New York (excluding NYC), Ohio, West Virginia
Summary of Job:
The Regional Account Manager (RAM) – Rare Disease is a critical commercial role responsible for expanding the diagnosed patient population and driving appropriate treatment initiation through education-driven, data-informed field engagement. This role is designed to complement existing Regional Business Manager (RBM) coverage by placing primary emphasis on new and earlier patient identification, diagnostic pathway enablement, and referral network activation.
In rare disease markets, where growth is driven by patient identification rather than market share shifts, the Regional Account Manager focuses on uncovering diagnostic gaps, enabling earlier disease recognition, and ensuring appropriate handoff of qualified patient opportunities to RBMs for treatment initiation and account execution. The RAM serves as a field integrator across the local ecosystem and works in close collaboration with Regional Business Managers and relevant cross-functional partners
Essential Functions:
Patient Identification & Diagnostic Enablement
Territory Strategy & Data-Driven Execution
Cross-Functional Collaboration
Compliance & Professional Conduct
Success Metrics (KPIs)
Primary Metrics
Secondary Metrics
Job Requirements:
Education
Experience
Preferred Qualifications
Travel Requirements
Technical Skills
Non-Technical Skills
The anticipated salary for this position will be $185,500 to $202,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 212 Carnegie Center Dr. Suite 510 Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.
Recruitment & Staffing Agencies
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
#LI-PE1
#LI-Field
Ready to apply?
Apply to Kyowa Kirin North AmericaShare this job
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.
Summary:
The Senior Director, GRA Development & Product Strategy Team Lead is responsible for the developing and implementing regulatory strategies, while leading people amd managing global projects. This role oversees a team of Global Regulatory Leads (GRL) supporting global products and may serve as a Regional Regulatory Lead (RRL) based on business needs.
Essential Functions:
• Define and drive global regulatory strategies for all products within the assigned disease area, ensuring alignment with enterprise objectives and maximizing product value.
• Lead and develop a team of Global Regulatory Leads (GRLs), setting direction, building capabilities, and fostering a high-performance, accountable culture.
• Shape and integrate regulatory strategy into global product development and lifecycle plans in close partnership with cross-functional stakeholders.
• Oversee and ensure execution of regulatory strategies, including global submissions, approvals, and post-approval activities across assigned products and projects.
• Direct and represent the organization in interactions with health authorities, including leading negotiations and overseeing agency meeting strategy and execution.
• Guide and approve global regulatory submission plans, including marketing applications, labeling (e.g., CCDS), and key lifecycle deliverables.
• Manage and coordinate regulatory activities, timelines, and deliverables across internal teams and external partners, ensuring alignment and on-time execution.
• Ensure compliance with global regulatory requirements, internal policies, and GxP standards, including support for inspections, audits, and governance processes.
• Assess and communicate regulatory risks, emerging trends, and competitive intelligence, escalating issues and recommending mitigation strategies as appropriate.
• Drive operational excellence by leading process improvements, standardization efforts (e.g., SOPs/WIs), and adoption of best practices across Regulatory Affairs.
• Oversee external partnerships and due diligence activities, including vendor selection, alliance management, and regulatory support for business development transactions.
• Contribute to organizational leadership, including participation in RA Functional Teams (RAFTs), budget oversight, and fostering collaboration across Regulatory Affairs and the broader organization.
• Establish and maintain global labeling strategy, including oversight of Company Core Data Sheet (CCDS) development and alignment with regional labeling requirements.
• Allocate and optimize regulatory resources across the portfolio, ensuring effective prioritization and support for key business objectives.
• Recruit and build organizational capability by leading talent acquisition, succession planning, and ongoing training initiatives within the regulatory function.
• Ensure alignment with Vision 2030, company Core Values, Kabegoe Principles, and the Global Regulatory Affairs Vision.
Requirements:
Education
Bachelor’s degree in life sciences, pharmacy, or a related scientific discipline required. Advanced degree (e.g., MS, PhD, PharmD, MBA) is preferred but not required; relevant industry experience may be considered in lieu of advanced education.
Experience
• Minimum 12+ years extensive regulatory affairs experience within the pharmaceutical, biotechnology, or related industry, including global development and lifecycle management, with a focus on bone and mineral disease areas.
• Proven leadership experience, including managing and developing high-performing regulatory teams and/or leading through other leaders (e.g., GRLs)
• Demonstrated success in developing and executing global regulatory strategies across multiple regions and product stages (development through post-approval)
• Significant experience interacting with health authorities, including leading regulatory agency meetings and negotiations
• Cross-functional leadership experience, with a strong track record of influencing stakeholders and driving alignment across complex, matrixed organizations
• Experience supporting business development activities, including regulatory due diligence for in-licensing, out-licensing, or partnerships Strong collaboration across cross-functional teams including regulatory affairs, government affairs, clinical, legal, and R&D.
Technical Skills
• Deep knowledge of global regulatory frameworks and guidelines, including major markets (e.g., FDA, EMA, ICH,PMDA) and their application to drug development and lifecycle management
• Expertise in regulatory submissions and approvals, including INDs/CTAs, NDAs/BLAs/MAAs, and post-approval variations
• Strong understanding of global labeling requirements, including development and maintenance of Company Core Data Sheets (CCDS)
• Advanced regulatory strategy development and risk management skills, with the ability to anticipate challenges and drive solutions
• Familiarity with GxP requirements and regulatory compliance standards, including inspection and audit readiness
• Proficiency in regulatory systems, tools, and document management platforms used for submissions, tracking, and compliance
• Strong organizational and project management skills with the ability to manage multiple initiatives simultaneously.
• Exceptional communication and influencing skills, with the ability to clearly articulate complex regulatory strategies, risks, and requirements to diverse audiences, including health authorities, senior leadership, and cross-functional teams, to drive alignment and informed decision-making.
• Strong proficiency MS Office Suite.
Working Conditions:
Requires up to domestic and international travel.
The anticipated salary for this position will be $265,000-$285,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
#LI-TT1 #Hybrid #Princeton
Ready to apply?
Apply to Kyowa Kirin North AmericaShare this job
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.
Summary:
The Director, Clinical Science (non-hemato-oncology) is a vital position in our growing global organization. As part of the Clinical Science group, this person is a key member of multi-disciplinary project teams responsible for the achievement of milestones (e.g., IND, FIH, POC, EOP2, NDA) for development programs. It is expected for this role to exercise leadership in the scientific discussion in project teams from the clinical perspective, diving deeply into the science of her/his assigned program(s), and perform the role of a subject matter expert for the program(s). He/she will play an active role in the creation of regulatory documents (e.g., BB, IND), study protocols, and clinical development plans for new and/or launched products, including lifecycle management. He/she will be responsible for establishing and maintaining KOL relationships.
Essential Functions:
• Serve as leading voice on clinical matters as Clinical Science representative on assigned project team(s), based on firm understanding of given disease area(s) and of clinical development processes, especially in the US and Europe
• Lead in the formulation of clinical development strategies, in collaboration with related functions, and create clinical development plans, accordingly
• Lead in the formulation of clinical trial protocols with sufficient feasibility and high probability of success, based on significant expertise in new drug development
• Lead in the development of written material for clinical sections of key regulatory submissions; work closely with Regulatory in the process of preparing these submissions and ensure compliance with local regulatory requirements and standards throughout the course of clinical trials.
• Work closely with cross-functional teams, including Regulatory, Marketing, and Quality to support clinical trial design and execution, regulatory submissions, and launch-related activities.
• Provide input from the clinical perspective to the formulation of Target Product Profiles.
• Analyze safety and efficacy findings from clinical studies; participate in inter-disciplinary team meetings, as required
• Support required safety evaluations for clinical studies, e.g. AE assessment, as needed.
• Create and maintain good relationships with clinical investigators and relevant Key Opinion Leaders; identify physicians with potential to serve as strong investigators for clinical studies
• Attend relevant scientific meetings to strengthen competency in assigned field(s) and to gain awareness of research activities underway and activities of competitors
• Serve as an author and lead in the preparation of review articles and conference presentations, relating to assigned clinical trial(s)
• Support business development, as needed, in due diligence efforts of new in-licensing opportunities (or other topics).
• Foster and contribute to collaborative environment that seeks to encourage innovation, strengthen scientific understanding among team members, and enhance professional development for all.
• Perform other duties, as required.
Requirements:
Education
MD (or equivalent), PharmD, PhD in life sciences or related field; applicable R&D experience may also be considered.
Experience
• Minimum 10 years of relevant clinical research experience with at least 5 years in clinical development role
• Authorship and review of clinical development plans, clinical study protocols, briefing books, IBs, SAPs, and CSRs
• Significant experience and ability to work effectively with external partners, including physicians and vendors
• Preferred experience: leadership role in large, late-stage, global outcomes trials; background in Bone & Mineral or Rare Disease trials
Technical Skills
• Strong scientific background with good understanding of drug development process
• Good leadership skills, highly motivated, great attention to detail, ability to work in complex and changing situations, excellent problem-solving skills
• Broad level of interpersonal skills and flexibility; cultural sensitivity and ability to develop consensus within matrix structure of a multinational organization
• Excellent written and oral communication skills
• Good project management skills; able to organize and prioritize multiple activities
• Proficient in MS Office Suite, relevant software applications, using templates, and other electronic formats
• Ability to think analytically (in terms of both strategy and tactics) and simultaneously consider scientific, medical, and business aspects of projects
Working Conditions:
Requires up to 15% domestic and international travel
The anticipated salary for this position will be $225,000 to $285,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
#LI-TT1 #Hybrid #Princeton
Ready to apply?
Apply to Kyowa Kirin North AmericaShare this job
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.
Summary:
The Associate Director, Clinical Quality Management serves as the central Risk-Based Quality Management (RBQM) Lead for Clinical Operations, responsible for enterprise-wide, proactive risk management across clinical trials. This role owns the end-to-end RBQM framework, including risk identification, assessment, mitigation, centralized monitoring, lessons learned, and maintenance of a clinical risk library, ensuring risks are managed consistently and intelligently across studies, programs, vendors, and regions. The role partners cross-functionally to embed risk-based decision-making into study design, execution, oversight, and continuous improvement, in alignment with ICH E6 (R3), GCP, and global regulatory expectations.
Essential Functions:
Risk-Based Quality Management (RBQM) Leadership
• Lead the design, implementation, and continuous evolution of a holistic RBQM framework across Clinical Operations, aligned with ICH E6 (R3) and regulatory guidance.
• Serve as the central RBQM authority ensuring consistent risk management approaches across trials, programs, regions, and vendors.
• Integrate RBQM principles into study planning, execution, oversight, and close-out activities.
• Provide expert oversight and guidance to study teams on study-level RBQM plans, ensuring alignment with enterprise risk strategy.
Central Risk Identification, Monitoring & Mitigation
• Lead proactive, cross-study and cross-functional risk assessments to identify systemic, emerging, and study-specific risks.
• Define, standardize, and maintain Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) across trials.
• Oversee centralized risk monitoring and trending to enable early detection of critical risks.
• Partner with study teams to develop and oversee risk mitigation, contingency, and escalation plans, ensuring inspection Lessons
Learned & Risk Library Management (Core Ownership)
• Establish and maintain a centralized Clinical Risk Library, capturing:
o Known and emerging risks
o Root causes
o Mitigation strategies
o Effectiveness of controls
• Lead lessons learned activities across trials, audits, inspections, and CAPAs.
• Ensure lessons learned are:
o Systematically captured
o Analyzed for trends
o Fed back into RBQM planning, SOPs, training, and future studies
• Drive organizational learning by translating lessons learned into preventive, forward-looking risk controls.readiness.
Quality Oversight & Regulatory Compliance
• Ensure clinical trial conduct complies with GCP, regulatory requirements, and company SOPs.
• Provide centralized quality oversight across trials, CROs, and vendors.
• Support audit and inspection readiness activities, including:
o Risk-based inspection preparation
o Impact assessments
o CAPA development and effectiveness checks
Vendor & CRO Risk Oversight
• Design and implement risk-based oversight strategies for CROs and external vendors.
• Monitor vendor performance using quality metrics and risk indicators.
• Lead or support quality governance discussions with external partners.
• Ensure vendor-related risks are integrated into the central risk library and lessons learned framework.
Data-Driven Quality & Continuous Improvement
• Leverage data analytics and centralized monitoring tools to enable real-time risk detection and decision-making.
• Generate enterprise-level risk trend reports and insights for senior leadership.
• Continuously refine RBQM methodologies based on data, inspection outcomes, and lessons learned.
• Champion a culture of proactive quality and continuous improvement across Clinical Operations.
Cross-Functional Collaboration & RBQM Expertise
• Act as the RBQM Subject Matter Expert (SME) for Clinical Operations and Clinical Quality Compliance.
• Provide RBQM training and coaching to study teams and cross-functional stakeholders.
• Collaborate closely with Regulatory, Biostatistics, Data Science, QA, and Vendor Management teams to align risk strategies and metrics.
• Participate as an observing member on assigned study teams to provide real-time quality and risk support.
SOP Management & Governance Support
• Partner with Document Control and SOP Administration teams to ensure RBQM and lessons learned are reflected in SOPs, WIs, and templates.
• Support governance activities, senior management reporting, and quality metrics standardization.
• Recommend and support implementation of corrective and preventive actions to protect system, process, and data integrity.provide real-time quality and risk support.
Requirements:
Education
• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Public Health, or related field (required)
• Advanced degree in Clinical Research, Quality Management, Regulatory Affairs, or Data Science (preferred)
Experience
• 10+ years of experience in Clinical Operations, Clinical Quality, RBQM, or RBM
• Demonstrated experience leading enterprise or cross-study risk management frameworks
• Strong background in audit/inspection readiness, CAPA management, and vendor oversight
• Deep knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements
Technical Skills
• Expertise with RBQM tools, centralized monitoring systems, and risk analytics
• Experience defining and using KRIs, QTLs, and quality metrics
• Familiarity with CTMS, eTMF, and data visualization tools (Spotfire, Tableau, Power BI)
• Exposure to AI or predictive analytics for quality monitoring (preferred)
Working Conditions:
Requires up to 25% domestic and international travel. May involve working outside of regular business hours to accommodate global time zones and project deadlines.
The anticipated salary for this position will be $175,000 to $190,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
#LI-TT1 #Hybrid #Princeton
Ready to apply?
Apply to Kyowa Kirin North AmericaShare this job
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.
Summary:
The Specialist, Bioanalytical, Translational Research supports multiple pharmaceutical development programs by managing clinical sample use and disposition for biomarker testing, coordinating with external vendors, and providing data analysis support to biomarker teams. This role also facilitates collaboration with project teams and contributes to related clinical trial activities as needed.
Essential Functions:
• Implement and coordinate with other functional areas to institute processes for clinical sample management, from informed consent to data generation, including biobanking processes.
• Support biomarker teams in managing biomarker activities, such as organizing and analysis of biomarker data, conducting biomarker data verification and quality control, etc.
• Assist in coordinating and overseeing vendors for biomarker and bioanalytical assays, including selection, contracting, performance monitoring, and collaboration with colleagues across regions (e.g., Japan) and functions (Clinical Operations, Biometrics, Medical Sciences). Represent Translational Research on study teams.
• Maintain and keep bioanalytical assay and clinical study-related files and documents organized and archived in the trial master file (TMF).
• Ensure regulatory and procedural compliance by following applicable standards, guidelines, and regulations for patient sample handling and biomarker data management.
• Contribute to process improvement and innovation by developing optimized methods for sample handling, data management, and integration of results into the design of new clinical studies.
• Develop and maintain SOPs and related documents (manuals, work instructions) for sample acquisition, handling, and use.
• Collaborate across functions to support departmental and company goals, including contributions to study action plans and broader program objectives.
Requirements:
Education:
Bachelor’s degree in Biology, Biochemistry, Molecular Biology, Pharmacology or closely related discipline. Masters degree a plus.
Experience:
• Minimum 2 years of experience in bioanalytical, translational research, or clinical research settings, preferably in the pharmaceutical or biotechnology industry.
• Exposure to handling and processing clinical samples, including sample tracking and storage.
• Hands-on experience with biomarker assays, data analysis, or quality control activities.
• Participation in cross-functional project teams or collaborative research initiatives.
• Experience interacting with external vendors or laboratory partners is a plus.
Technical Skills
• Knowledge of bioanalytical and biomarker assay principles, sample handling, and biobanking processes.
• Familiarity with clinical sample documentation and regulatory requirements (e.g., GCP, SOPs, TMF).
• Proficiency in basic data analysis and reporting using standard software tools (e.g., Excel, GraphPad, or equivalent).
• Strong organizational skills with the ability to track multiple samples, datasets, and projects.
• Effective written and verbal communication skills for scientific documentation and cross-functional collaboration.
• Ability to follow protocols, standard operating procedures, and quality guidelines with attention to detail.
• Familiarity with scientific analytical software (JMP, R, Etc)
• Proficient in MS Office Suite
Working Conditions:
Requires up to 5% domestic and international travel
The anticipated salary for this position will be $90,000 to $105,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
#LI-TT1 #Hybrid #Princeton
Ready to apply?
Apply to Kyowa Kirin North AmericaShare this job
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.
Summary:
The Manager, R&D QA, Global Audits, Inspections and R&D Quality is responsible for managing Quality Assurance systems, processes and conducting internal and external audits and reviews, training, and reporting according to KK standards. The R&D QA Manager will support the QA program to assure the accuracy and quality of scientific data submitted to regulatory agencies in support of new drug applications and/or biological licensing agreement applications. The R&D QA Manager will collaborate and provide key quality input to KK’s R&D function.
Essential Functions:
• Serve as key point of contact for GCP/GLP quality issues reported by KK staff and provides ongoing feedback to management on potential quality-related risks. Involvement in clinical trials includes, but is not limited to, independent review and approval of deviations and CAPAs, GCP guidance, and quality agreement preparation.
• Perform and report assigned GCP/GLP audits of KK studies, including clinical investigator sites, vendors/CROs, internal systems/processes, and clinical data/documents, as applicable.
• Prepare timely, high-quality audit reports; evaluate audit responses; and oversee CAPA development, adequacy, implementation, and tracking in accordance with KK standards.
• Maintain expert-level knowledge of global GCP/GLP regulations and industry expectations. Serve as a subject matter expert to KK staff, provide interpretation of regulatory requirements, and actively contribute to the company’s Regulatory Intelligence program.
• Design and deliver GCP training to KK staff to enhance compliance awareness, inspection readiness, and quality culture.
• Support continuous improvement initiatives; develop, revise, and administer SOPs and controlled documents; and ensure effective maintenance within quality document management systems.
• Participates in Health Authority inspection activities for domestic and international projects (as applicable).
• Provides input to the annual risk-based audit plan, schedule and execution of audits based on changing business environment and interaction with cross-functional teams.
• Undertake other QA-related duties as directed by the supervisor to support departmental and organizational objectives.
Requirements:
Education
Bachelor’s degree in Life Science or closely related scientific discipline (e.g., Pharmacy, Chemistry, Microbiology, Biology, or Pharmaceutical Sciences) required
Experience
• Minimum three (3) experience in drug development in GCP/GLP Quality Assurance, including hands-on experience in auditing, CAPA management, and deviation review.
• Demonstrated knowledge of global regulatory requirements, including EMA, FDA, MHRA, ICH, and other applicable standards, with proven ability to interpret and apply them in operational settings.
• Experience supporting Health Authority inspections, including preparation, participation, and follow-up actions.
• Proven track record in developing and implementing risk-based audit plans, SOPs, and quality systems, with experience in quality document management.
• Experience in training and mentoring staff on GCP/GLP compliance and fostering a culture of quality.
• Exposure to global, cross-functional collaboration with clinical, regulatory, and operational teams on QA-related matters.
• Prior involvement in vendor/CRO management, clinical site audits, and quality agreement development is highly desirable.
Technical Skills
• Experience with Veeva or other electronic Quality Management Systems (eQMS) for document control, audit tracking, and CAPA management.
• Ability to generate comprehensive audit reports and perform trend analysis.
• Familiarity with regulatory intelligence tools and systems to track evolving GCP/GLP requirements.
• Strong skills in risk assessment and quality metrics reporting.
• Excellent written and verbal communication skills for interacting with internal teams and external regulatory authorities.
• Proficiency in MS Office Suite (Word, Excel, PowerPoint, Outlook) for reporting, data analysis, and presentations.
Working Conditions:
Requires up to 20% domestic and international travel
The anticipated salary for this position will be $135,000 to $150,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
#LI-TT1 #Hybrid #Princeton
Ready to apply?
Apply to Kyowa Kirin North AmericaShare this job
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.
This territory covers parts of Charlotte, NC; Columbia, SC; and extends south to Charleston, SC. Candidates must be willing to travel throughout the territory
The Oncology Account Manager is a critical role in establishing KKNA as a leader in Oncology and Rare Diseases by demonstrating our commitment to supporting the efforts of Oncology/Rare Disease healthcare providers in improving patient health outcomes and becoming a trusted resource in demonstrating value along the patient journey. .
The individual in the role will drive an effective hospital system and account planning, management, and selling process for hospital systems/accounts. He/she will identify the key stakeholders within the assigned hospital systems/accounts and build strong relationships with those individuals along the patient journey. This includes understanding and educating referral networks to identify appropriate patients, converting to Poteligeo where appropriate, and ensuring maintenance on Poteligeo by supporting appropriate multidisciplinary support of the patients via their care network. The Oncology Account Manager also serves as the lead point of contact for account management activities within the assigned hospital networks, academic Institutions, and surrounding practices, working closely with Market Access, Sales, Marketing, and Medical Affairs Teams.
Essential Functions:
Job Requirements
Education
Experience
Technical Skills
Non-Technical Skills
Highly motivated and with great attention to detail. Strong endurance to work under tight timelines and complex/changing situations. Excellent written and oral communication skills including the ability to present via PowerPoint in front of large groups. Excellent problem-solving skills. Broad level of interpersonal skills and flexibility. Cultural sensitivity and ability to develop consensus within a multinational organization.
Physical Demands:
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.
Recruitment & Staffing Agencies
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
Annualized base salary ranges from $150,000 – $175,000 plus sales incentive; actual salaries will vary and may be above or below this range commensurate with various factors including but not limited to experience, education, training, and merit.
This position is eligible for a company car through the Company’s FLEET program.
Kyowa Kirin provides a comprehensive compensation and benefits package which includes:
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Thank you for your interest in a career with Kyowa Kirin. Below you will find an application to join our Talent Community. After applying, you will be added to our talent pipeline for future opportunities.
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Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.
Summary:
The Veeva Vault Architect serves as the technical and strategic leader for designing, implementing and optimizing Veeva Vault solutions across the global organization. This role ensures that all Vault applications align with business objectives, regulatory requirements, and enterprise architecture standards. The architect collaborates closely with business stakeholders, IT teams and implementation / support partners to deliver scalable, compliant and high performing Vault-based solutions.
Essential Functions:
Solution Architecture & Design
• Develop end to end architecture for Veeva Vault applications (e.g., Quality, RIM, Medical, Commercial).
• Interpret business requirements into scalable, secure and compliant Vault configurations.
• Define data models, object structures, workflows, lifecycle states and security models.
• Establish integration patterns between Vault and other enterprise systems (ERP, LMS, MDM, LIMS, etc.).
• Create architectural standards, design documents and technical specifications.
Platform Leadership
• Serve as the subject matter expert for Veeva Vault capabilities, limitations and best practices.
• Guide configuration teams on Vault objects, metadata, workflows and automation.
• Familiarity with domain level configuration and best practices.
• Evaluate new Vault features and releases, advising on adoption and impact.
• Ensure alignment with GxP, 21 CFR Part 11, Annex 11, and other regulatory frameworks.
Implementation & Delivery
• Lead technical workstreams during Vault implementations, migrations and enhancements.
• Oversee data migration strategies, mapping, cleansing and validation.
• Support test planning, execution, and defect resolution for configuration and integrations.
• Partner with project managers to ensure delivery timelines and quality standards are met.
Integration & Data Management
• Architect and oversee integrations using native Veeva Vault Integrations, Veeva APIs, Vault Loader and middleware tools across both Vault and other applications.
• Ensure adherence to data governance, master data strategies and cross system data flows.
• Ensure data integrity, auditability, and traceability across the Vault ecosystem.
Stakeholder Collaboration
• Work with business process owners to understand needs and translate them into technical solutions.
• Collaborate with QA/SA, Compliance, Data Privacy and Validation teams to ensure system readiness.
• Provide technical guidance to internal teams and external implementation partners.
Operational Excellence
• Establish monitoring, performance optimization and support frameworks.
• Develop documentation, SOPs and knowledge transfer materials.
• Support ongoing enhancements, change requests and continuous improvement initiatives.
Requirements:
Education
Bachelor’s degree or equivalent experience in computer science, information systems, engineering or related fields required. Veeva Vault certification(s) preferred.
Technical Skills
• 8+ years of experience in the configuration, implementation, support and operations of Veeva Vault-based solutions.
• Proven expertise across multiple functional domains (Quality, Regulatory, Medical, Commercial and/or Clinical).
• Hands-on experience with Veeva APIs, integration patterns and data migration tools.
• Knowledge of GxP compliance, validation practices and regulated system requirements.
• Experience with large-scale, global implementations.
• Experience with middleware platforms (e.g., MuleSoft, Informatica), Master Data Management concepts and solutions preferred.
Working Conditions:
Requires up to 10 % domestic and international travel.
Willingness to work in a global environment with the ability to adapt to diverse cultural norms, including different communication styles, time zones, holiday schedules, and management approaches.
The anticipated salary for this position will be $185,000 to $200,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
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Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.
Summary:
The Associate Director, Regulatory Affairs, Advertising and Promotion Compliance will independently review, approve, and monitor product advertising and promotional labeling material for an assigned product to ensure compliance with US regulatory requirements. In addition, the associate director will be responsible for supporting preparation of FDA Form 2253 submissions and any requests for advisory comment submissions to FDA's Office of Prescription Drug Promotion (OPDP) as well as submissions to PAAB for promotional materials in Canada, as applicable.
Essential Functions:
• The Associate Director is responsible for providing strategic and tactical regulatory support and guidance for assigned product and disease state communications as well as pipeline and non-promotional communications.
• Provides guidance and input for assigned development products reflective of promotional considerations, including assessment of potential labeling claims.
• Serves as Promotional Review Committee (PRC) chair and as the primary regulatory reviewer of advertising, promotions, and other related materials for assigned product to ensure compliance with applicable FDA/Health Canada laws, regulations, and guidance.
• Works collaboratively with cross-functional partners, including Legal and Medical as part of PRC. Develops solutions to complex promotional issues by utilizing scientific and regulatory knowledge to support business objectives and initiatives while effectively identifying, escalating, and managing business risks.
• Serves as the regulatory reviewer for the Medical Review Process (MRC) for assigned product(s).
• Provides direction and works collaboratively to ensure that changes in US Prescribing Information and Canadian Product Monograph are reflected in current promotions and advertising
• Continually assesses the advertising and promotion related
process to enhance efficiencies and compliance.
• Collaborates in cross-functional efforts to develop, update, and implement policies, procedures and guidelines related to Regulatory Advertising and Promotion Compliance.
• Primary liaison with Office of Prescription Drug Promotion (OPDP) regarding advertising and promotion for assigned products.
• Monitors US and Canadian regulatory promotional environment and stays abreast of all relevant regulatory and industry changes and updates related to FDA and Health Canada guidance, warning letters, enforcement actions and regulations; and communicate to appropriate internal and external personnel in a timely manner, highlighting the implications of the changes
• Ensures the maintenance of paper and electronic records of all submissions and communications with OPDP, and any supporting documentation
• Provide relevant regulatory compliance training to staff and cross-functional partners from a regulatory perspective.
Requirements:
Education
Bachelor’s degree in life science or closely related discipline. Advance degree preferred (Pharm.D., Phd, M.S, JD)
Experience
• Minimum seven (7) years of progressive experience in the pharmaceutical or biotechnology industry, specifically in Regulatory Affairs with a focus on Advertising and Promotion (Ad/Promo).
• Proven track record as the primary regulatory reviewer for promotional and non-promotional materials across various therapeutic areas, ensuring compliance with FDA regulations, industry guidelines (e.g., OPDP, PhRMA), and internal policies.
• Strong experience in leading and managing Regulatory review processes within cross-functional Medical, Legal, and Regulatory (MLR) teams for both consumer and professional marketing materials.
• Familiarity with launch planning, including pre-approval communications, disease awareness campaigns, and launch materials.
• Experience with training Commercial and cross-functional teams on promotional compliance principles, regulatory changes, and industry best practices.
• Preferred, but not required, experience with reviewing promotional and non-promotional communications in Canada to be compliant with Health Canada regulations.
Technical Skills
• Thorough knowledge of applicable regulations, guidance, and industry standards related to advertising and promotional communications about prescription drugs, devices (if applicable), and investigational treatments in the US
• Understanding of clinical study design and statistical analyses in assessment of promotional claims
• Excellent written, verbal, and presentation skills, with the ability to communicate effectively across all levels of the organization.
• Solid proficiency using Microsoft Office Suite including Word, Excel, and Power Point for documentation, analysis, and presentations.
• Experience with Veeva, SharePoint and Box
Working Conditions:
Requires up to 10% domestic and international travel
The anticipated salary for this position will be $____ to $____. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
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Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.
Summary:
The Associate Director, ERP Functional & Solution Architect, ICT role will be responsible for overseeing MS D365 Enterprise Resource Planning (ERP) within the organization. Crucial role in implementing ERP specific business process improvements and enhancements within the organization and ensuring the system's optimal performance and functionality. Perform the planning, design, configuration, customization, and implementation of MS D365/ERP modules and functionalities, ensuring seamless integration with existing systems, ensuring compliance with industry standards, security protocols, and regulatory requirements. The ERP Functional Architect, Associate Director, ICT role will also serve as a business process analyst aligned with enterprise (i.e., SCM, MFG, Quality) and Corporate Functions (i.e., Finance, HR, Legal, Compliance, Procurement) ensuring successful technical solution development and delivery.
Essential Functions:
The D365 ERP F&O Functional Architect is responsible for the end-to-end functional design, configuration, and optimization of Microsoft Dynamics 365 Finance & Operations to support business operations across Finance, Procurement, Supply Chain, Manufacturing, Quality, and related business functions. The architect will partner with business stakeholders, technical teams, and implementation partners to ensure that the solution is aligned with corporate strategy, compliant with GxP/GAMP 5 standards (where applicable), and scalable for future business growth.
1. Solution Architecture & Design
• Lead the functional design and architecture of the D365 F&O solution across key modules (Finance, Supply Chain, Manufacturing, Procurement, Inventory, Quality, etc.).
• Translate complex business requirements into clear, scalable, and compliant functional solutions.
• Emphasizes proactive, holistic leadership in solution architecture.
• Focuses on aligning solutions with business goals, value streams, and enterprise architecture governance.
• Define data flows, integrations, and system interactions between D365 and other enterprise systems & interfaces (e.g., LIMS, MES, 3PL Partners, External Finance Systems, and Cloud systems).
• Ensure alignment with Microsoft’s Dynamics 365 roadmap and best practices.
2. Implementation & Configuration
• Perform and lead the setup, configuration, and deployment of D365 F&O modules.
• End to end management of project/solution management by using tools like Azure Boards for planning and tracking work, Azure Repos for code versioning, and Azure Pipelines for automating build and deployment. Perform all activities from initial user stories and tasks to code, testing, and deployment through integrations with tools like Lifecycle Services (LCS).
• Drive fit-gap analysis and functional documentation. Develop User/Functional Requirements, Functional/Technical Design, System/Business process architecture diagrams.
• Collaborate with development/vendor/managed service teams to define functional specifications for enhancements, bug/fix, customizations, reports, and interfaces. Co-develop or individually develop code/configurations required and coordinate internal development and user acceptance testing of the solution.
• Participate in system validation activities, including IQ/OQ/PQ documentation for regulated environments.
3. Governance & Compliance
• Ensure the ERP system design complies with GAMP 5, SOX, and GxP regulatory requirements.
• Develop and maintain master data governance, change management, and configuration control processes.
• Support audits and inspections through proper documentation and traceability.
• Develop current and future state roadmaps and architecture.
• Assess and align system release plan with Microsoft Dynamics 365 roadmap
4. Stakeholder Collaboration
• Partner with business process owners to define best practices, continuous improvement opportunities, and confirm desired solution to fix the support/bug-fix items raised. Support communities of practice and collaborative development methodology.
• Work independently to perform required fix within the D365 framework. Test and confirm the developed fix with business process owners.
• Work closely with IT, OT, and cloud teams to ensure integrated digital architecture.
• Provide subject matter expertise and training for internal business process owners and super users.
5. Project & Vendor Management
• Support ERP implementation and upgrade projects through all phases — initiation, design, testing, go-live, and hypercare.
• Manage and coordinate external implementation partners and vendors.
• Define KPIs and monitor system performance, adoption, and ROI.
Requirements:
Education
Bachelor’s degree or equivalent experience in computer science, information systems, engineering, supply chain, or related fields required. Microsoft D365 F&O Certification preferred.
Experience
• 8+ years of experience implementing or supporting Microsoft Dynamics AX / D365 F&O.
• Proven expertise across multiple functional domains (Finance, Manufacturing, Supply Chain, Procurement).
• Experience designing integrations between ERP and external systems (LIMS, MES, Payment interface with Bank, External Finance Systems, etc.).
• Strong understanding of ERP data models, workflows, and reporting.
• Strong understanding of functional and solution architecture of, and experience performing code and configuration updates within the following Dynamics 365 modules:
o Finance: General ledger, Cash and bank management, Accounts payable, Accounts receivable. Budgeting, Fixed assets, Cost accounting, PR/PO process, Vendor Management, Cost Accounting and Management
o SCM: Inventory management, Master planning, Procurement and sourcing, Product information management, Production control, Warehouse management, Cost accounting, Cost management, Asset management, including scheduled maintenance and repair tasks
Technical Skills
• Proficient in MS Office Suite. Experience with technology delivery applications across solutions such as (ERP, Manufacturing Execution Systems, Finance Systems, Control Tower).
• Microsoft Certified: Dynamics 365: Finance and Operations Apps Solution Architect Expert certification preferred.
• Experience with emerging technologies (AI/ML, cloud, etc.) as relevant to ERP.
Working Conditions:
Requires up to 10 % domestic and international travel
The anticipated salary for this position will be $165,000 to $190,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
#LI-TT1 #Hybrid #Princeton
Ready to apply?
Apply to Kyowa Kirin North AmericaShare this job
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.
Summary:
We are seeking a Security Operations Specialist to join our Global Information Security team. This role will serve as the regional lead for North America security operations and OT/ICS security, responsible for incident response, monitoring, and cyber defense across IT and manufacturing environments. The ideal candidate will have strong experience in SOC operations, OT cybersecurity, and regulated industries, with the ability to respond under pressure while also driving continuous improvement.
Essential Functions:
• Lead incident response for North America, coordinating with the global SOC for escalations, investigations, and recovery.
• Manage monitoring solutions to ensure high-quality visibility across IT, cloud, and OT environments.
• Own OT/ICS cybersecurity strategy in partnership with manufacturing, infrastructure, and plant leadership, securing SCADA, PLCs, and lab systems.
• Vendor management for proactive threat hunting, pen testing and forensic analysis.
• Lead remediation activities for both IT and OT environments.
• Drive regional execution of global SOC playbooks, escalation models, and threat intelligence integration.
• Develop and maintain operational security runbooks and ensure continuous improvement of detection and response capabilities.
• Partner with IT, R&D, and Manufacturing to enforce regulatory compliance across GxP, HIPAA, and FDA-controlled systems.
Requirements:
Education
Bachelor’s degree in Information Security, Computer Science, or related field required; Advanced training in OT/ICS security preferred.
Certifications Required: CISSP
Certifications Preferred: GICSP, GRID, or other OT-focused certifications
Experience:
At least 5 years in cybersecurity operations, with demonstrated experience in SOC or incident response leadership; Strong hands on experience with OT/ICS environments in pharma, biotech, manufacturing, or critical infrastructure; Expertise in SIEM, SOAR, forensic tools, and threat detection engineering; Knowledge of OT security frameworks (ISA/IEC 62443, NIST CSF) and pharmaceutical regulations (GxP, HIPAA, 21 CFR Part 11).
Technical Skills
• Expertise in Security Operations and Incident Response, including triage, investigation, containment, and recovery across IT, cloud, and OT environments.
• Hands-on experience with SOC technologies such as SIEM, SOAR, EDR/XDR, and forensic analysis platforms.
• Strong background in OT/ICS cybersecurity, including SCADA, PLCs, and lab systems, with application of frameworks such as ISA/IEC 62443 and NIST CSF.
• Knowledge of threat detection engineering, use-case development, and integration of threat intelligence into monitoring workflows.
• Proficiency in forensic tools and malware analysis to support root-cause identification and post-incident review.
• Understanding of regulatory compliance requirements including GxP, HIPAA, and 21 CFR Part 11, as they apply to manufacturing and research systems.
• Experience collaborating on vulnerability management, patching, and remediation across IT and OT environments.
Working Conditions:
Requires up to 10 % domestic and international travel
The anticipated salary for this position will be $115,000 to $130,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
#LI-Tt1 #Hybrid #Princeton
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