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 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
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.
#L!-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.
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.
#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.
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.
#LI-SH1
Ready to apply?
Apply to Kyowa Kirin North AmericaShare this job
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.
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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 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.
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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 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 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.
#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.
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.
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