The Manufacturing Operations Supervisor provides front-line supervision for the manufacturing support function, ensuring safe, compliant, and reliable execution of daily operations in accordance with cGMP requirements. This role coordinates core support activities including media preparation, material kitting, and GMP cleaning to enable on-time manufacturing execution by following the approved schedule and standard work. The supervisor assigns daily work, supports training and qualification compliance, addresses routine operational issues, and escalates constraints, deviations, and staffing concerns to management as appropriate. This position partners with Manufacturing, Quality, Supply Chain, Training, and Facilities to maintain operational continuity and serves as a floating supervisor, providing supervisory coverage for the Cell Processing team as needed.
Supervision & Leadership
•    Provide day-to-day supervision and guidance for the manufacturing support team, reinforcing safe, efficient, and compliant execution of assigned operations
•    Assign and coordinate daily workload and priorities across media preparation, material kitting, GMP cleaning, and related support activities to meet production demand
•    Maintain routine floor presence and conduct shift huddles to communicate priorities, monitor progress, and reinforce standard work and cGMP behaviors
•    Provide coaching and on-the-job guidance; document observations and communicate recurring performance concerns to management/HR for follow-up as needed
•    Promote a culture of safety, quality, and accountability through clear expectations, timely feedback, and consistent follow-through
Production & Scheduling
•    Coordinate end-of-day cleaning activities to support next-day readiness; ensure tasks are executed and documented and communicate any missed activities and recovery needs
•    Coordinate daily/weekly support execution (materials, media, and cleaning) to align with the production plan; communicate readiness and issues to the appropriate stakeholders
•    Partner with the Manufacturing Scheduler to align priorities and communicate schedule impacts and constraints; support mitigation actions as directed
•    Coordinate shift coverage (including time-off coverage) and communicate coverage risks to management; support coverage plans to minimize impact to operations
•    Support timely task execution by removing routine barriers, adjusting priorities within the shift, and escalating issues that may impact schedule adherence
•    Track and communicate shift performance items (e.g., completion status, documentation issues, and safety/quality observations) and escalate recurring issues for corrective action
Manufacturing Compliance
•    Provide daily floor-level quality oversight for the support team by reinforcing procedures, safety expectations, and Quality System requirements
•    Verify manufacturing documentation is completed correctly and on time, including Batch Records and Electronic Batch Records (EBRs); coordinate timely correction of errors and coaching to prevent recurrence
•    Review batch records, SOPs, and logbooks for accuracy and completeness; route documentation per procedure and promptly escalating discrepancies to Quality and Manufacturing management
•    Support internal and external audits and inspections by ensuring documentation readiness for the shift and by completing assigned follow-up actions within required timelines
System & Documentation Management:
•    Perform and verify accurate ERP transactions supporting manufacturing execution (e.g., material requisitions/allocation, production tracking, and work order updates)
•    Oversee documentation-related workstreams (labels, EBR updates, media and materials requests), ensuring prioritization, accuracy, and on-time completion
•    Author and updated controlled documents (e.g., SOPs, deviations, protocols) in alignment with GMP requirements; route completed documents for review and approval through the appropriate Quality Systems workflow
•    Ensure training records are current and audit-ready; verify team compliance with required curricula, certifications, and role-based qualification plans
Continuous Improvement & Operational Efficiency
•    Collaborate with cross-functional stakeholders to identify operational risks, capacity constraints, and resource needs; escalate findings and support mitigation plans as directed
•    Coordinate evaluation and implementation of new materials and equipment by defining user requirements, supporting trials, and confirming readiness for GMP use
•    Maintain visibility to improvement ideas, deviations/operational issues, and employee concerns; track progress and escalate unresolved items to leadership
•    Participate in and support continuous improvement activities (standardization, 5S, waste reduction, error-proofing) to improve safety, quality, and cycle time
•    Participate in cross-functional projects as a team representative to support manufacturing support capability and business continuity

Team Development & Training
•    Provide training support for material kitting and cleaning (as a trainer and/or by coordinating with qualified trainers) to support consistent execution to approved procedures
•    Coach employees on standard work and GMP expectations; reinforce good practices through routine observations and feedback
•    Coordinate with Training to schedule and complete required curricula; identify training gaps and communicate needs and impacts to management
•    Monitor training completion and communicate non-compliance or qualification risks; support recovery actions as directed
•    Support onboarding and orientation for new team members by coordinating training plans and documenting progress toward role qualification milestones
Administrative & Communication Responsibilities
•    Manage shift handoffs and coverage changes, assign daily responsibilities, and represent the team in daily/departmental communications as needed
•    Communicate status, risks, and needs to the manager and partner departments to support timely issue resolution in a fast-paced manufacturing environment
•    Provide clear, timely written communication (emails, shift updates, and documentation) to ensure alignment and traceability
Additional Responsibilities
•    Provide supervisory coverage across manufacturing operations as needed to maintain safe, compliant, and uninterrupted execution
•    Ensure manufacturing areas remain clean and inspection-ready, including equipment staging, waste management, and housekeeping to established standards
•    Support initiatives that improve team performance against safety, quality, delivery, and compliance expectations; reinforce gains through standard work
•    Perform other duties as assigned to support departmental objectives and changing business needs

Qualifications
Education / Training
•    Bachelor’s degree or equivalent experience in a related field (e.g., Life Sciences, Manufacturing, or Engineering)
Experience/Education
•    AS/BS in Biotechnology, Biology, Chemistry or equivalent
•    Minimum 4+ years of experience in a manufacturing or GMP environment 
•    2+ years of experience in lead, training, or coordination role 
Knowledge/Skills
•    Strong knowledge of GMP guidelines, safety protocols, and regulatory requirements
•    Familiarity with ERP systems (Sage X3 or similar) and document management systems
•    Good communication, leadership, and problem-solving skills
•    Ability to work in a fast-paced environment while maintaining high standards of quality and compliance
•    Technical writing experience is a plus (e.g., SOPs, deviation reports, protocols)

Statistical Programmer Contractor

Position Summary:

The Statistical Programmer Contractor is responsible for developing, validating, and maintaining SAS programming deliverables to support clinical study analysis and reporting. This role collaborates closely with Biostatistics and other cross-functional team members to produce high-quality, compliant datasets, tables, listings, and figures while ensuring adherence to project timelines, SOPs, regulatory requirements, and CDISC standards.

Responsibilities:

• Program and validate tables, listings, figures, and derived datasets using SAS.
• Develop SDTM and ADaM datasets and supporting documentation.
• Prepare and review mapping specifications and annotated case report forms (CRFs).
• Perform quality control and validation activities for programming deliverables.
• Collaborate with study team members to identify, investigate, and resolve data and output issues.
• Review study documents and provide input to improve programming quality, efficiency, and consistency.
• Maintain complete, accurate, and audit-/inspection-ready programming documentation.
• Communicate project status, risks, issues, and timeline impacts clearly to stakeholders.

 Qualifications:

• Bachelor’s degree required; Master’s degree preferred in Statistics, Biostatistics, Mathematics, Computer Science, or a related field.
• Minimum of 10 years of relevant statistical programming experience within the pharmaceutical, biotechnology, or CRO industry.
• Phase 3 and regulatory submission experience preferred.
• Strong SAS programming skills, with experience developing SDTM, ADaM, tables, listings, and figures.
• Strong knowledge of clinical trial processes, regulatory requirements, and programming documentation.
• High attention to detail, with strong analytical, problem-solving, and communication skills.

Position Summary:

The Statistical Programmer Contractor is responsible for developing, validating, and maintaining SAS programming deliverables to support clinical study analysis and reporting. This role collaborates closely with Biostatistics and other cross-functional team members to produce high-quality, compliant datasets, tables, listings, and figures while ensuring adherence to project timelines, SOPs, regulatory requirements, and CDISC standards.

Responsibilities:

• Program and validate tables, listings, figures, and derived datasets using SAS.
• Develop SDTM and ADaM datasets and supporting documentation.
• Prepare and review mapping specifications and annotated case report forms (CRFs).
• Perform quality control and validation activities for programming deliverables.
• Collaborate with study team members to identify, investigate, and resolve data and output issues.
• Review study documents and provide input to improve programming quality, efficiency, and consistency.
• Maintain complete, accurate, and audit-/inspection-ready programming documentation.
• Communicate project status, risks, issues, and timeline impacts clearly to stakeholders.

 Qualifications:

• Bachelor’s degree required; Master’s degree preferred in Statistics, Biostatistics, Mathematics, Computer Science, or a related field.
• Minimum of 10 years of relevant statistical programming experience within the pharmaceutical, biotechnology, or CRO industry.
• Phase 3 and regulatory submission experience preferred.
• Strong SAS programming skills, with experience developing SDTM, ADaM, tables, listings, and figures.
• Strong knowledge of clinical trial processes, regulatory requirements, and programming documentation.
• High attention to detail, with strong analytical, problem-solving, and communication skills.

The Manufacturing Specialist II, Cell Processing at ProKidney plays a critical role in supporting advanced manufacturing operations, focusing on cell processing activities and ensuring compliance with cGMP guidelines. This role involves setting up, operating, and maintaining production equipment, including control rate freezers and orbital shakers, performing final product freezing and storage, and providing guidance to junior staff while leading improvements in cell processing operations.

Essential Duties & Responsibilities:

• Lead and participate in cell processing activities, ensuring compliance with cGMP guidelines and ProKidney’s manufacturing standards.
  • Read, understand, and implement Standard Operating Procedures (SOPs) for all assigned tasks, providing guidance to other team members as needed.
  • Set up, operate, and troubleshoot production equipment such as control rate freezers, orbital shakers, etc., ensuring optimal performance and maintaining preventive maintenance schedules.
  • Perform final freezing and storage of cell therapy products in LN2, ensuring adherence to specified procedures and quality standards.
  • Revise, update, and ensure adherence to approved documents, including SOPs, batch records, and MS forms, maintaining GMP compliance.
  • Ensure the accuracy of GMP documentation, including batch records, logbooks, and forms, adhering to Good Documentation Practices (GDP).
  • Train and mentor junior team members in cell processing techniques, procedures, and cGMP compliance.
  • Perform and support investigations into deviations, incidents, and process improvements.
  • Lead efforts in process development, qualification, and validation activities as needed.
  • Ensure all activities comply with safety policies, rules, and regulations, and promote a safe working environment.
• Conduct aseptic manufacturing processes in a cleanroom environment, ensuring compliance with sterile techniques and regulatory standards.

Secondary Responsibilities:

• Lead and assist in material qualification tests to ensure the suitability of manufacturing materials.
  • Provide guidance and support for continuous process improvement initiatives.
  • Assist in data collection, analysis, and reporting for process optimization and regulatory submissions.
  • Perform other duties as assigned to support and improve manufacturing operations.

Minimum Qualifications:

• Education/Training: AS/BS in Biotechnology, Biology, Chemistry, or related field; a Science-related discipline is preferred. Relevant experience may substitute for formal education. High School Diploma or Equivalent may be considered with significant relevant experience.
  • Experience: Preferred minimum 2-4 years of relevant experience in cell processing, biotechnology manufacturing, or a related field, with at least 1-2 years of proven expertise in a cGMP-regulated environment.
  • Skills/Abilities: Ability to exercise independent judgment, lead teams, and ensure compliance with cGMPs. Strong computer skills, including Microsoft Office, and expertise in ERP systems, along with advanced organizational, record-keeping, and time management skills.
  • Other: Strong problem-solving skills, effective written and oral communication, a team-oriented approach, and a commitment to high-quality work are critical for success in this role.

The Mfg Cell Processing Specialist 3 at ProKidney plays a critical role in supporting advanced manufacturing operations, focusing on cell processing activities and ensuring compliance with cGMP guidelines. This role involves operating and maintaining production equipment, including control rate freezers and orbital shakers, performing final product freezing and storage, and driving continuous improvement. The Mfg Specialist 3 is responsible for mentoring team members, leading investigations, and ensuring high levels of quality and compliance.

Responsibilities:

• Lead and oversee cell processing activities, ensuring compliance with cGMP guidelines and ProKidney’s manufacturing standards.
• Read, understand, and implement Standard Operating Procedures (SOPs) for all assigned tasks, providing guidance to team members.
• Set up, operate, and troubleshoot production equipment such as control rate freezers, orbital shakers, etc., ensuring optimal performance and preventive maintenance.
• Perform final freezing and storage of cell therapy products in LN2, ensuring adherence to procedures and maintaining quality standards.
• Revise, update, and ensure adherence to SOPs, batch records, and MS forms, maintaining GMP compliance.
• Lead routine cycle counts and ensure accurate inventory tracking and control.
• Execute transactions within the ERP system, including material requisitions and production tracking.
• Ensure the accuracy of GMP documentation, including batch records, logbooks, and forms, adhering to Good Documentation Practices (GDP).
• Lead investigations into deviations and Corrective and Preventative Actions (CAPA) efforts, compiling data and information as required.
• Provide mentorship and training to junior team members in cell processing techniques, procedures, and cGMP compliance.
• Drive continuous improvement, incident investigations, and deviation resolutions.
• Perform and support investigations into deviations, incidents, and process improvements.
• Ensure all activities comply with safety policies, rules, and regulations, and promote a safe working environment.
• Conduct aseptic manufacturing processes in a cleanroom environment, ensuring compliance with sterile techniques and regulatory standards.
• Perform material qualification tests to qualify lots of incoming manufacturing material.
• Support process development and validation activities as needed.
• Assist in data collection, analysis, and reporting for process optimization and regulatory submissions.
• Perform other duties assigned to support and improve manufacturing operations.

Qualifications:

• AS/BS in Biotechnology, Biology, Chemistry, or related field; a Science-related discipline is preferred. Relevant experience may be a substitute for formal education. High School Diploma or Equivalent may be considered with significant relevant experience.
• Preferred minimum 4-6 years of relevant experience in cell processing, biotechnology manufacturing, or a related field, with at least 2-3 years of proven expertise in a cGMP-regulated environment.
• Ability to exercise independent judgment, lead teams, and ensure compliance with cGMPs.
• Strong computer skills, including Microsoft Office, and expertise in ERP systems, along with advanced organizational, record-keeping, and time management skills.
• Strong problem-solving skills, effective written and oral communication, a team-oriented approach, and a commitment to high-quality work are critical for success in this role.

ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

The QA Specialist 2 provides essential Quality Assurance support to Quality Operations, with a primary focus on material and batch release activities. Working within established GMP processes and under moderate supervision, this role contributes to maintaining compliance with Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGxP) regulations. The successful candidate applies developing professional knowledge, strong attention to detail, and effective communication skills to support documentation, compliance monitoring, and quality system activities in a fast-paced pharmaceutical environment.

Key Responsibilities

GMP Database & Documentation Support

• Maintain accurate and consistent tracking, data entry, and follow-up within departmental GMP databases under established procedures
• Prepare and conduct initial reviews of batch and material release documentation, ensuring conformance with applicable SOPs, specifications, and acceptance criteria
• Evaluate completed manufacturing, filling, labeling records, and analytical data for compliance with regulatory standards and company requirements; escalate discrepancies to senior QA staff
• Report key quality metrics and performance indicators as required, using established templates and reporting tools

Production Monitoring & Product Compliance

• Perform hands-on monitoring of production and non-production activities; identify and report observed non-compliance to Quality Management in a timely manner
• Support confirmation that finished products conform to government and company standards and meet cGxP regulations
• Participate in internal and external audits, including customer and regulatory audits, as directed by Quality Management

Deviation & CAPA Support

• Assist in investigating deviations under the guidance of senior QA staff; contribute to root cause identification and propose corrective actions for review and approval
• Identify compliance risks and effectively communicate observations to senior management; support the implementation of assigned action plans to mitigate risks
• Promptly escalate critical quality issues to senior management with relevant documentation and context

Quality System & Procedure Support

• Regularly review and update GMP system procedures to ensure alignment with current regulatory standards and company policies, as assigned
• Review and provide input on SOPs, change control documents, and protocols related to cGxP programs as assigned by management
• Assist in the implementation and maintenance of regulated Quality Systems under the direction of senior QA personnel

Collaboration & Professional Development

• Collaborate with internal departments to support the implementation of quality principles and regulatory requirements
• Maintain up-to-date knowledge of industry trends, standards, and methodologies related to cGxP and GMP through continuous learning
• Apply developing technical and analytical skills while building professional judgment and deepening subject matter knowledge

Qualifications

Education/Experience

• Associate’s Degree + years of relevant experience in a GMP-regulated environment, OR Bachelor’s Degree in Life Sciences, Chemistry, Pharmacy, or a related field + 2 years of relevant experience in a GMP-regulated environment

Knowledge

• Working knowledge of GMP and cGxP regulations as they apply to pharmaceutical manufacturing and quality operations
• Familiarity with deviation management and CAPA processes; experience participating in or supporting investigations preferred
• Basic familiarity with FDA, EU, and/or ISO regulatory frameworks preferred

Skills

• Communicates professionally, clearly, and concisely — both verbally and in writing — with internal and external stakeholders
• Strong attention to detail with the ability to maintain accuracy in documentation and data entry under defined processes
• Able to organize and prioritize assigned work effectively to meet timelines with quality deliverables
• Works collaboratively within a team environment; receptive to feedback and committed to continuous improvement
• Proficient with Microsoft Word, Excel, and Adobe; experience with electronic batch record or LMS systems a plus

The Manufacturing Support Specialist III plays a key leadership role in supporting manufacturing operations, with a primary focus on aseptic processing, GMP cleaning, and adherence to cGMP guidelines. This position requires a high level of expertise in performing complex aseptic processing of in-house solutions, preparing materials and kits, managing GMP areas, and ensuring stringent compliance with Standard Operating Procedures (SOPs). The role also involves actively participating in document revision, providing training and mentoring to junior staff, and assisting in deviation and CAPA (Corrective and Preventive Action) investigations. As a senior position, the Specialist III will be a key contributor to maintaining high standards of GMP documentation and will work with a high degree of accountability and independence to ensure the continuous improvement of manufacturing operations.

Key Responsibilities:

Aseptic Processing & GMP Maintenance:

• Perform aseptic processing of in-house solutions according to current cGMP guidelines, ensuring all processes maintain the highest standards of sterility and quality.
• Participate in material kit preparation, ensuring alignment with Good Documentation Practices (GDP) and cGMP standards.
• Perform and oversee cleaning and sanitization of GMP areas and manufacturing equipment following approved cleaning procedures and industry best practices.
• Ensure proper documentation of cleaning and maintenance activities, including batch records and logbooks, in strict adherence to GMP and GDP standards.
• Support the maintenance of the clean room environment, ensuring it remains below alert level limits and is consistently compliant with cleanliness standards.

Documentation & Compliance:

• Review, revise, and update SOPs, batch records, and other manufacturing documents to maintain compliance with current regulatory requirements and best practices.
• Complete and ensure the accuracy of GMP documentation, including batch records, logbooks, and forms, in compliance with GDP.
• Participate in internal and external audits, supporting the team in ensuring compliance with regulatory bodies, including the FDA.
• Monitor and support compliance with GMP standards and assist with deviation investigations, ensuring corrective actions are implemented where necessary.

Training, Mentoring & Leadership:

• Mentor and train new and less experienced staff on manufacturing processes, GMP procedures, and safety protocols.
• Lead by example to foster a culture of compliance and quality, ensuring all team members follow established guidelines and safety regulations.
• Assist in training initiatives for the broader team, focusing on aseptic techniques, GMP best practices, and proper documentation practices.
• Support the continuous improvement of manufacturing processes and SOPs through participation in cross-functional meetings and projects.

Material & Equipment Management:

• Conduct routine cycle counts in cleanrooms to ensure accurate inventory levels and prevent shortages.
• Manage and execute routine transactions in the ERP system, including material requisitions, production tracking, and inventory management.
• Ensure proper handling, storage, and documentation of materials and equipment to prevent contamination and maintain compliance with GMP standards.

Safety & Process Improvement:

• Promote and enforce adherence to safety policies and procedures to prevent workplace accidents and injuries.
• Proactively identify deviations from SOPs and GMP standards and take immediate corrective action.
• Assist in the implementation of Corrective and Preventive Actions (CAPAs), identifying root causes of issues and ensuring solutions are effectively put in place.
• Support process optimization initiatives and work with teams to improve operational efficiencies while maintaining regulatory compliance.

Collaboration & Data Collection:

• Collaborate with cross-functional teams, including production, quality assurance, and engineering, to ensure seamless operations and continuous adherence to manufacturing standards.
• Assist in data collection efforts for troubleshooting, CAPA investigations, and other manufacturing-related tasks.
• Provide insights and contribute to the development of new procedures, technologies, and improvements within manufacturing operations.

Secondary Responsibilities:

• Perform additional tasks as needed to support the manufacturing team and ensure the smooth operation of the manufacturing process.
• Contribute to data analysis and reporting efforts as directed.

Minimum Qualifications:

Education/Training:

• AS/BS in Biotechnology, Biology, Chemistry, or a related field; a Science-related discipline is preferred.
• High School Diploma or equivalent may be considered with relevant experience.
• Certification in aseptic techniques or GMP training is preferred.

Experience:

• 2-4 years of relevant experience in biotechnology manufacturing, GMP environments, or a related field.
• Demonstrated experience with aseptic techniques, GMP cleaning, and working in a regulated environment.
• Experience with SOP revision, documentation control, and deviation/CAPA investigations is preferred.

Skills & Abilities:

• Strong knowledge of cGMP and GDP standards, with the ability to follow production schedules and SOPs.
• Proficiency in aseptic gowning, aseptic processing, and performing in a team-oriented environment.
• High level of attention to detail and the ability to manage multiple tasks and priorities effectively.
• Strong computer skills, including proficiency in Microsoft Office, ERP systems, and other relevant software tools.
• Excellent organizational, record-keeping, and time management abilities.
• Ability to communicate effectively, both written and verbally, with a diverse team and in cross-functional environments.
• Ability to exercise independent judgment, solve problems, and identify improvements.

Other:

• Strong eye/hand coordination and commitment to maintaining a high quality of work.
• A leadership mindset with the ability to mentor and train others.
• Willingness to wear protective clothing and equipment as required in a GMP environment.
• Ability to lift and move objects up to [specific weight, e.g., 25 pounds].

Physical Requirements:

• Ability to stand for extended periods and perform repetitive tasks.
• Capability to lift and move objects up to [specific weight, e.g., 25 pounds].
• Willingness to wear protective clothing and equipment as required.

Position Summary

The Principal Training Liaison – Manufacturing is the functional authority for GMP training strategy within Manufacturing, shaping the curricula frameworks, qualification standards, and workforce capability models that underpin ProKidney's clinical and commercial readiness. This role establishes the methodologies, best practices, and performance standards that define how Manufacturing develops, qualifies, and sustains a compliant, high-performing workforce.

Operating at the intersection of regulatory science, adult learning, and manufacturing operations, this individual drives functional training strategy across Manufacturing and serves as a subject-matter authority and strategic consultant to QA, CMC, QC, Supply Chain, Facilities, and Engineering. This role anticipates compliance risk, proactively architects mitigation strategies, and influences cross-functional decisions that shape site-wide quality culture and inspection readiness. The Principal Training Liaison leads through expertise and influence, mentoring senior professionals and elevating the functional capability of the Manufacturing organization.

Key Responsibilities

GMP Training Strategy & Program Architecture

• Architect and own the end-to-end GMP training strategy for Manufacturing, establishing frameworks, methodologies, and evaluation standards that define the function's approach to workforce readiness.
• Define the instructional model for GMP onboarding, including competency benchmarks, qualification criteria, and bootcamp curriculum design; set the standard others across the site adopt and follow.
• Anticipate regulatory trends and evolving GMP expectations; proactively integrate emerging requirements into training strategy before gaps materialize.
• Serve as Manufacturing's senior representative during regulatory inspections, agency interactions, and internal audits; shape the training-related narrative and lead responses to inspector inquiries.
• Establish and maintain curriculum governance processes, ensuring training content is current, SOP-aligned, and reflective of operational and regulatory requirements.

Training Content Development & Functional Standards

• Define the standards and methodology for GMP training content development across Manufacturing, including SOP-based courses, e-learning modules, job aids, and instructor-led programs; serve as the functional benchmark for quality and effectiveness.
• Apply advanced instructional design principles and deep cGMP expertise to design high-impact training that drives measurable improvements in compliance, operational performance, and workforce capability.
• Establish a systematic training effectiveness framework — including assessment design, observational audits, and feedback mechanisms — to evaluate and continuously improve program outcomes.
• Deliver high-stakes, specialized instructor-led training for complex regulated operations (e.g., aseptic technique, cleanroom behaviors, advanced GMP topics) where subject-matter authority is essential.

Compliance Oversight & Risk Management

• Define and own training compliance standards for Manufacturing; establish the metrics, governance model, and accountability structures that sustain a ≥90% training adherence rate across the site.
• Set and continuously optimize the qualification pathway for new hires, ensuring all personnel are trained and operationally qualified within defined timelines (target: 14 weeks from hire).
• Serve as the site's functional authority on aseptic technique and cleanroom behavior training, establishing the standards and qualification criteria applied across all manufacturing roles.
• Lead the training-related root cause analysis and CAPA development process for deviations and audit findings; anticipate systemic compliance risks and develop proactive mitigation strategies.
• Own the annual curriculum and job code review process, aligning training requirements with evolving role responsibilities and regulatory expectations.

Cross-Functional Influence & Continuous Improvement

• Act as a strategic consultant to QA, CMC, QC, Supply Chain, Facilities, and Engineering, influencing cross-functional decisions related to training, operational readiness, and cleanroom impact.
• Lead the training and readiness strategy for new equipment qualifications, material changes, and process introductions; shape how change is absorbed and sustained across the manufacturing workforce.
• Develop and own the training and operational KPI framework for Manufacturing; translate performance data into strategic insights that inform leadership decisions and drive continuous improvement.
• Conduct targeted floor observations and internal compliance audits; synthesize findings into recommendations that influence site-wide quality systems and operational practices.
• Champion and model a culture of quality, safety, accountability, and continuous improvement; shape the behavioral norms and expectations that define ProKidney's manufacturing quality culture.

Trainer Development & Organizational Capability Building

• Define the qualification model, competency standards, and ongoing evaluation framework for GMP trainers; serve as the functional authority on trainer certification and effectiveness measurement.
• Architect and lead cross-functional mentorship and capability-building initiatives that elevate technical depth and instructional quality across Manufacturing and GMP functions.
• Drive long-term workforce capability strategies aligned with ProKidney's clinical and commercial growth trajectory; translate organizational milestones into proactive training roadmaps.

Qualifications

Education / Training

• Bachelor's degree in Life Sciences, Engineering, Education, or related field required
• Advanced degree (M.S., MBA, or equivalent) preferred
• Instructional Design certification (e.g., ATD, CPTD) or equivalent advanced experience preferred

Experience

• 8–12+ years of progressive experience in a GMP-regulated, FDA-compliant environment (biotech, pharma, or cell therapy strongly preferred)
• Demonstrated track record of owning and shaping GMP training strategy and program architecture — not just program execution
• Deep expertise in cGMP regulations, aseptic processing, cleanroom behaviors, and regulatory inspection expectations
• Experience influencing cross-functional decisions and serving as a strategic consultant to manufacturing and quality functions
• Proven ability to anticipate compliance risk and develop proactive mitigation strategies
• Experience with Learning Management Systems (e.g., MasterControl) and advanced instructional design methodologies

Skills & Competencies

• Functional authority in instructional design and advanced cGMP principles; recognized as a go-to expert within and beyond the function
• Strong strategic thinking and business acumen; ability to connect training outcomes to organizational and regulatory imperatives
• Exceptional communication, facilitation, and influencing skills across all levels of the organization, including senior leadership
• Ability to synthesize complex data and translate insights into strategic recommendations that drive decision-making
• Proven cross-functional collaboration and consultant-style engagement with partner functions
• Continuous improvement mindset with demonstrated ability to drive systemic, lasting change

Position Summary

The Senior Talent Acquisition Coordinator manages the logistics and administrative operations of the hiring process, ensuring a smooth and positive candidate experience.  This role supports recruiters and hiring managers through interview scheduling, ATS management, and onboarding coordination. The position requires strong organization, communication, and proficiency with HR software systems. This role supports a fast‑paced Talent Acquisition function and requires comfort working with confidential information, managing shifting timelines, and coordinating across cross‑functional teams.

This is a hybrid position based in Winston‑Salem, NC, requiring three days per week onsite, with additional onsite days as needed.

Responsibilities

• Partner with TA colleagues to schedule candidates using Greenhouse applicant tracking system. Contribute to a successful candidate and hiring manager experience by ensuring all necessary details are communicated to candidates and interviewers in a timely manner. Work with Corporate Traveler to coordinate candidate travel and logistics. Maintain candidate records in Greenhouse, ensuring accuracy, confidentiality and compliance.
• Collaborate with TA Partners to develop offer letters, launch background investigations and conduct timely candidate references. Track HireRight background investigations through completion. Collaborate with TA Partners to resolve any discrepancies/issues.
• Build strong relationships with candidates, ensuring clear communication and a positive experience throughout the hiring process.
• Manage job postings and maintain accurate applicant records in the Applicant Tracking System (ATS).
• Work with TA Partners to coordinate expense reporting and reimbursement.
• Supports Talent Acquisition by assisting with TA project tasks, running reports as needed, and managing related activities within the ATS.
• Provides logistical support for Talent Acquisition events and assists with event coordination and execution as needed.

Qualifications

• 5+ years of experience in recruiting coordination, HR operations, or a fast-paced administrative role.
• Strong organizational skills with the ability to manage multiple calendars and shifting priorities.
• Excellent verbal and written communication skills for interactions with candidates and hiring managers.
• Proficiency with ATS platforms and Microsoft Office Suite
• High attention to detail, reliability, and a service‑oriented mindset.
• High School diploma required; Bachelor’s degree preferred or an equivalent combination of education and experience.

Position Summary

The Associate Director of Validation will lead the Qualification and Validation teams at the site. Serve as a member on project steering, value stream and quality systems performance teams. Establish operational objectives and systems to drive employee engagement and alignment with other departments. Deliver on site objectives while implementing harmonized engineering systems and processes. Provide leadership support to the other sites and validation initiatives as needed. Will lead system validation projects related to authoring and executing validation documentation for laboratory instruments/equipment and systems according to the ISPE GAMP 5 Validation Life Cycle as well as 21CFR Part11 and FDA’s guide to Computer Software Assurance. Documentation includes System Validation Plan, User Requirements, Risk Assessment, IQ, OQ, PQ, Test Scripts, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer Systems, and Data Integrity Assessment.

Responsibilities

• Provide leadership and direction to Validation team members, driving performance and value creation to the site function operational and strategic plans and tasks
• Ensure adequate resourcing (capacity and capability) to accomplish site and OST objectives. Recommend solutions to alleviate constraints
• Regularly interacts with senior management or executives on multi-department projects and challenges. Able to build coalitions for change.
• Continuously improving the culture of the Validation team and the site
• Represents Validation and Emergent during GMP and other regulatory agency inspections (CDC, OSHA, etc.)
• Identify areas to drive down operations costs and improve project delivery efficiency. Develop specific investment strategies to realize these savings
• Hands on troubleshooting and problem solving at the Gemba in support of engineering team members and operations
• Develop and lead small and medium sized continuous improvement projects, remain involved in projects led by staff members
• Direct support to OST head or lead annual OPEX budget for Validation department
• Staff and System Development
• Effective delegation and building confidence and competence within direct reports
• Drive engagement in the technical and personal development of the Validation team and members
• Develops strong relationships with partners (QA, Mfg., etc.) and cultivates these with all team members
• Provide effective and collaborative cross functional leadership to facilitate development of the site strategy and delivery of site objectives
• Champion and enhance the culture of the Validation team

Qualifications

• Bachelor’s degree. Preferred Fields of Study: Life Sciences or Engineering
• A minimum of 10 years of experience in a biopharmaceutical or related environment in an engineering or quality related role, with at least 5 years in a leadership role
• Expert knowledge of GxPs, GAMP, CFRs/Annex 11, and Data Integrity requirements for laboratory systems and equipment (Understanding of data integrity principles and security controls including, but not limited to audit trail reviews, user access roles, disaster recovery, business continuity, system implementation, change control, archival, retirement, etc)
• Strong understanding of Validation Lifecycle (GAMP 5) principles
• Experience with calibration and maintenance management software
• Knowledge of electronic document management systems
• Experience with data integrity practices and compliance
• Strong technical writing skills for qualification documents, SOPs, and work instructions
• Ability to manage multiple projects simultaneously with minimal supervision
• Detail-oriented with excellent verbal and written communication abilities
• Ability to adapt to changing priorities in a deadline-oriented environment
• Significant hands-on experience and regulatory expectations knowledge with controls, automation and computer system validation.
• Knowledge of pharmaceutical equipment, such as bioreactors, centrifuges, HVAC systems, building chillers, clean steam generators, and Temperature Controlled Units (e.g. refrigerators, freezers, and incubators) is an advantage.
• Strong knowledge and experience in cGMP, root cause analysis, risk assessment and investigation tools/techniques.
• Experience in writing computer system test scripts, validation protocols and summary reports

The Associate Director, Manufacturing Operations is responsible for leading GMP
manufacturing operations while developing and sustaining a highly capable, compliant, and
production-ready workforce. This role integrates strategic operational leadership with end-to-end
ownership of manufacturing programs, ensuring alignment with GMP, aseptic processing, and
regulatory expectations.

This leader oversees daily manufacturing execution, material readiness, and production support
activities while designing and driving robust training strategies that ensure continuous
operational readiness. The role serves as a key business partner to Manufacturing, Quality, and
cross-functional teams to enable safe, compliant, and efficient production while fostering a
culture of quality, accountability, and continuous improvement.

Essential Duties & Responsibilities:
· Provide leadership for GMP manufacturing operations, ensuring safety, quality, and production
targets are consistently achieved while driving right-first-time execution.
· Oversee material readiness, batch preparation, labeling verification, and production
coordination to support uninterrupted manufacturing operations.
· Own audit readiness of cleanrooms and minimize equipment downtime for schedule adherence
of manufacturing activities
· Own and lead the manufacturing training strategy, including onboarding, OJT programs,
aseptic qualifications, and continuous workforce development.
· Partner with Quality to lead deviation investigations, CAPAs, and change controls, ensuring
strong documentation practices and sustained audit readiness.
· Oversee aseptic and controlled environment operations, ensuring all personnel are properly
trained, qualified, and compliant with GMP standards.
· Drive continuous improvement initiatives across operations and training by identifying gaps,
optimizing processes, and enhancing efficiency and compliance.

ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed,
color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status,military
status, application for military service or any other class protected by state or federal law.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Education/Training:
· Bachelor’s degree in Life Sciences, Engineering, Operations Management, or related field
required; Master’s degree preferred
Experience:
· 7+ years of direct manufacturing experience in GMP-regulated pharmaceutical, biotech, or cell
therapy manufacturing
· 5+ years of managerial experience directly managing people and leadership experience leading
teams.
· 5+ years of GMP training program development, instructional design, and LMS management
· Demonstrated leadership experience in manufacturing operations, training, or both
· Experience with batch records, deviation management, CAPA, and working in
controlled/aseptic environments

Experience:
· Minimum 5 years of direct, hands-on manufacturing experience in a GMP-regulated
environment, including managerial responsibilities and proven leadership in operational settings.
· 5+ years of experience developing GMP training programs, instructional design, and managing
learning management systems, preferably with a background in manufacturing operations.

Knowledge:
· Strong knowledge of cGMP, GDP, and global regulatory requirements (FDA, EMA)
· Expertise in aseptic processing and manufacturing compliance standards
· Familiarity with ERP/MES/eQMS systems (e.g., SAP)

Skills:
· Strong leadership, coaching, and team development capabilities
· Expertise in training program development, instructional design, and management
· Excellent technical writing skills (SOPs, deviations, training materials)
· Strong problem-solving, communication, and cross-functional collaboration skills
Certifications/Licenses:
· None required; relevant GMP or instructional design certifications preferred

Position Summary:

The Team Lead, Cell Processing serves as a technical resource within the manufacturing team, supporting daily cell processing operations in a cGMP-regulated environment. This role provides on-the-floor guidance to manufacturing staff, supports execution of cell processing activities, and assists the Shift Manufacturing Supervisor with coordination of production activities. The Team Lead functions as a leader in manufacturing processes, promotes adherence to cGMP and aseptic techniques, and contributes to operational consistency, training, and continuous improvement.

This position is located onsite in Winston Salem, NC.

Essential Duties & Responsibilities:

• Provide on-the-floor leadership and technical guidance during cell processing operations, supporting the manufacturing team in executing production activities safely and
• Serve as a technical guide for cell processing operations, including cell culture, expansion, harvesting, formulation, and cryopreservation.
• Support coordination of daily manufacturing activities to ensure alignment with the production schedule and operational priorities.
• Assist in task coordination and workflow organization during manufacturing operations to support efficient execution of batch activities.
• Perform complex or critical manufacturing steps in a cleanroom environment in accordance with cGMP and aseptic processing requirements.
• Support troubleshooting of process or equipment issues and escalate concerns to the Manufacturing Supervisor when appropriate.
• Assist with review of batch documentation, logbooks, and manufacturing records to ensure accuracy and adherence to Good Documentation Practices (GDP).
• Support the development and training of manufacturing personnel on cell processing techniques, SOPs, and cleanroom practices.
• Contribute to deviation investigations, CAPA activities, and process improvements by providing technical input and operational knowledge.
• Assist with implementation or revision of manufacturing procedures, batch records, and documentation as processes evolve.
• Participate in daily tier meetings and communicate operational updates, risks, or resource needs to the Supervisor.
• Maintain compliance with safety procedures, cGMP regulations, and internal quality
• Support audit readiness and participate in inspections as
• Perform other duties as assigned to support manufacturing

Minimum Qualifications:

• Education/Training: AS/BS in Biotechnology, Biology, Chemistry, or equivalent; preferred area of study in a Science-related discipline. High School Diploma or Equivalent with relevant experience may be considered.
• Experience: Preferred minimum 4 years of relevant experience in biotechnology manufacturing or a related field.
• Skills/Abilities: Proficiency in biological processing techniques such as cell culture, ultra-filtration, and column Advanced knowledge of cGMP facilities and requirements. Strong organizational skills with the ability to manage multiple projects and meet deadlines. Critical thinking ability and judgment to make appropriate decisions within defined procedures.
• Other: Excellent eye/hand coordination, effective written and oral communication skills, team-oriented with a strong work ethic.

Position Summary

The Quality Assurance (QA) Specialist III provides independent, real-time QA support within classified manufacturing areas, including cleanrooms. The Specialist III applies solid cGMP expertise to perform documentation review, issue identification, escalation, and accurate records to ensure cGMP compliance. The role requires shift work, full gowning, on-floor presence, and collaboration with Manufacturing, Quality Control, Facilities, and other stakeholders to ensure compliant and efficient manufacturing operations.

This role is an onsite position in Winston Salem, NC requiring full‑time presence in classified manufacturing environments. Due to the hands‑on, real‑time nature of quality activities, this role is not eligible for remote or hybrid work.

Essential Duties & Responsibilities

• Provide QA review of moderate‑complexity manufacturing operations in classified environments.
• Maintain continuous on‑floor presence to support compliance, production activities, and issue resolution.
• Conduct complex in‑process batch record reviews and evaluate documentation for compliance and accuracy.
• Review manufacturing records, environmental monitoring data, and related documentation.
• Perform and verify line clearance activities for assigned processes.
• Identify, document, and resolve standard quality issues; escalate higher-risk or non-routine issues as required.
• Support and contribute to deviation investigations, CAPAS, and remediation activities.
• Review and approve facility alarms, work orders, and return‑to‑service documentation.
• Participate in internal audits, inspections, and cross‑functional quality initiatives.
• Follow all gowning, safety, and cleanroom behavior requirements.

Education & Experience Requirements

• Bachelor’s degree in an applied science field or equivalent experience.
• 5 years of QA experience in a GMP‑regulated manufacturing or quality environment
• Aseptic manufacturing experience preferred.

Knowledge & Skills

• Solid professional knowledge of cGMP regulations and quality systems.
• Ability to apply judgement to moderately complex quality issues.
• Strong documentation, analytical and problem-solving skills.
• Effective cross-functional communication and collaboration.
• Ability to manage multiple priorities with limited supervision.

Working Conditions

• This position requires full‑time onsite work in a GMP manufacturing environment.
• Not eligible for remote or hybrid work.
• Requires full gowning and extended time in cleanroom and classified areas.
• Ability to stand for extended periods and perform physical tasks as required.

The Associate Director of EHS – is responsible for leading and executing environmental, health, and safety programs across all ProKidney sites and operations to ensure regulatory compliance and a safe working environment. This role provides oversight for EHS strategy and partners cross-functionally with Manufacturing, Quality, Facilities, Supply Chain, and Laboratory teams to implement standardized safety programs, conduct risk assessments, manage hazardous materials and waste programs, and promote a proactive culture of safety consistent with regulatory and industry standards across the organization.

Essential Duties & Responsibilities

• Lead the development, implementation, and continuous improvement of EHS programs across all ProKidney sites, supporting laboratory, manufacturing, and operational environments.
• Establish standardized EHS policies, procedures, and safety management systems to ensure consistent safety practices across multiple locations.
• Conduct Job Hazard Analyses (JHAs), safety inspections, and risk assessments to identify hazards and implement mitigation strategies across facilities.
• Ensure organizational compliance with federal, state, and local environmental and safety regulations, including OSHA, EPA, CDC, and applicable biosafety and laboratory safety standards.
• Provide oversight of site EHS leads or local safety representatives, ensuring alignment with company-wide safety expectations and regulatory requirements.
• Oversee laboratory safety programs including chemical hygiene, biosafety practices, hazardous materials handling, and safe laboratory operations.
• Lead investigations of safety incidents, near misses, and environmental events across sites and drive corrective and preventive actions to prevent recurrence.
• Develop and deliver EHS training programs related to laboratory safety, chemical handling, hazardous waste management, emergency response, and workplace safety.
• Support hazardous waste management programs, chemical inventory systems, and environmental compliance programs across facilities.
• Partner with Quality and operational leadership to support internal audits, regulatory inspections, and continuous improvement initiatives across all ProKidney locations.
• Monitor EHS performance metrics and drive initiatives that improve safety culture, reduce risk, and support operational excellence.

Education / Training

• Bachelor’s degree in Environmental Health & Safety, Environmental Science, Industrial Hygiene, or related field preferred.

Experience

• 7–10+ years of Environmental Health & Safety experience, preferably within biotechnology, pharmaceutical, or life sciences manufacturing environments.
• Experience supporting multi-site operations or enterprise EHS programs in regulated environments.
• Experience supporting GMP manufacturing operations and regulatory compliance programs.
• Experience implementing safety management systems, risk assessments, and environmental compliance programs within regulated industries.

Knowledge

• Working knowledge of OSHA, EPA, and applicable environmental health and safety regulations.
• Understanding of laboratory safety standards, biosafety practices, and hazardous materials management.
• Knowledge of EHS governance models supporting multi-site organizations.

Skills

• Strong analytical and problem-solving skills with the ability to conduct hazard assessments and risk evaluations.
• Effective communication and training capabilities across scientific and operational teams.
• Ability to partner cross-functionally with Quality, Manufacturing, Facilities, Supply Chain, and laboratory personnel across multiple sites.
• Strong documentation and regulatory compliance mindset.
• Ability to influence safety culture and drive organizational alignment across geographically dispersed teams.

Certifications / Licenses

• Associate Safety Professional (ASP), Certified Safety Professional (CSP), or equivalent certification preferred.
• Biosafety or laboratory safety certification preferred.

Position summary

The Senior QA Specialist – QC Laboratory Operations is an experienced QA professional responsible for providing independent Quality Assurance review, guidance, and compliance support for Analytical and Microbiology laboratory operations within a regulated cell therapy manufacturing environment. This role applies advanced knowledge of cGMPs, laboratory quality expectations, and data integrity principles to ensure testing activities meet internal and regulatory requirements while maintaining a high state of readiness for audits and inspections.

This position is required to be onsite in Winston Salem, NC.

Primary Responsibilities: 

Essential Duties & Responsibilities

• Ensures quality and compliance for Analytical and Microbiology laboratory operations in alignment with cGMP requirements, internal quality standards, and regulatory expectations.

• Perform QA review and approval of laboratory documentation including analytical raw data, microbiological test results, environmental monitoring data, and associated data packages to ensure accuracy, completeness, and data integrity.

• Review and support laboratory quality events including deviations, OOS/OOT investigations, environmental monitoring excursions, and associated CAPA activities.

• Review and approve change controls, laboratory methods, equipment qualification documentation, validation protocols/reports, and laboratory SOPs to ensure compliance with regulatory and internal quality requirements.

• Conduct routine GxP walkthroughs of QC laboratory areas to identify compliance risks, drive timely resolution of observations, and promote inspection readiness.

• Serves as QA lead for laboratory inspection readiness activities and provides QA representation during internal audits, regulatory inspections, and quality assessments.

• Provides QA direction for analytical testing, microbiological methods, and laboratory quality expectations supporting cell therapy manufacturing through cross-functional collaboration with QC Laboratories, Manufacturing, Quality Systems, ASAT, and Regulatory Affairs.

Education/Training

Bachelor’s degree in Life Sciences, Microbiology, Chemistry, Biotechnology, or a related scientific discipline required. Advanced degree (MS or equivalent) preferred.

Experience

• Minimum 8 years of Quality Assurance or Quality Control experience in a regulated biopharmaceutical, biologics, cell therapy, or sterile manufacturing environment.

• Experience reviewing laboratory data under cGMP requirements.

• Experience supporting laboratory investigations including deviations, OOS, OOT, and environmental monitoring excursions.

• Experience supporting internal audits or regulatory inspections preferred.

Knowledge

• Strong understanding of cGMP regulations, 21 CFR Parts 210/211, 21 CFR Part 1271, and ICH guidelines.

• Knowledge of ALCOA+ data integrity principles and laboratory documentation standards.

• Understanding of analytical instrumentation, microbiological testing methods, method validation, and equipment qualification

Skills

• Strong analytical and problem-solving abilities. • Excellent attention to detail and quality decision-making.

• Strong communication and cross-functional collaboration skills.

• Ability to manage multiple priorities in a fast-paced GMP manufacturing environment.

• Ability to identify compliance risks and support implementation of corrective actions.

Position Summary:

The Quality Assurance On-The-Floor (OTF) Manager is responsible for leading the QA On-The-Floor team and providing real-time quality oversight of clinical and commercial manufacturing activities at ProKidney’s cGMP site. Reporting to the VP of Quality, this role managers daily floor support operations, ensures compliance with GMP and regulatory requirements, and partners closely with Manufacturing, Quality Control, Supply Chain, and Facilities to maintain a state of control on the production floor.
This position is located fully onsite in Winston Salem, NC. 

Team Leadership & Oversight

• Manage, develop, and coach the QA On-the-Floor team; ensure training, qualification, and performance expectations are met.
• Assign and approve work performed by direct reports, including documentation reviews and floor support activities.
• Maintain team readiness by ensuring all OTF personnel remain gown-qualified and trained on current procedures.

Manufacturing Floor Support & Quality Oversight

• Oversee and publish daily/weekly QA floor support schedules aligned with the manufacturing schedule.
• Provide real-time QA presence on the manufacturing floor, including routine walkthroughs, observation of operations, support during processing, and reinforcement of cleanroom behaviors.
• Identify, document, and escalate GMP issues or atypical events during manufacturing.
• Perform and/or oversee real-time batch record review to ensure accuracy and completeness.

Quality Decision Making & Issue Resolution

• Make routine QA decisions related to room/equipment release, line clearance, and documentation accuracy.
• Support and/or approve alarms, return-to-service documentation, deviations, change controls, and other quality records related to floor operations.
• Partner with Manufacturing to troubleshoot operational issues and implement corrective actions.

Documentation & Compliance Activities

• Ensure timely review of GMP documents (forms, logbooks, testing documentation, alarms, kitting, etc.).
• Ensure quarantined materials are stored and managed appropriately post-manufacturing.
• Author, revise, and review SOPs and quality procedures related to on-the-floor operations.
• Support internal audits, regulatory inspections, and compliance initiatives.

Cross Functional Collaboration

• Collaborate in a fast-paced, matrixed environment to ensure alignment on quality expectations and operational priorities.
• Participate in cross-functional quality teams and process improvement initiatives.

Other Responsibilities

• Maintain standards for accurate documentation, data integrity, and compliance in all QA-OTF activities.
• Perform other duties as assigned.
• Education And Experience:
• Bachelor’s degree in applied science or related field.
• 5+ years relevant QA experience in cGMP aseptic manufacturing, preferred as Quality on the floor
• Proven, hands-on knowledge of commercial GMP regulations for sterile manufacturing
• Strong organizational, analytical, and time management skills.
• Ability to work well in a team environment with positive attitude.
• Excellent communication skills with strong attention to detail.
• Ability to handle multiple tasks simultaneously.
• Demonstrated working knowledge of FDA, EU, and ICH regulatory requirements.
• Physical ability to perform frequent tasks requiring strength and mobility.

Position Summary:

Provide support to develop and implement data repository and analytics tools in support of pharmaceutical regulated GMP (Good Manufacturing Practices) data and with the focus on manufacturing and quality domains.

Essential Duties & Responsibilities:

• Analyze business needs and requirements for data and analytics to support regulatory filings.
• Identify, classify, and map data sources.
• Build data lineage diagram from data source to analytics ready datasets
• Determine data curation requirements to help organize, clean, manage, and maintain data so it can be used reliably for analytical use cases.
• Provide support for technical activities such as building data integration, design data architecture, and data transformation and processing.
• Develop data governance standards to comply with company and industry best practices.
• Lead development of key project documents such as user requirements, design specifications, and configuration specifications.
• Lead development of test scenarios and scripts in partnership with business, technical, and validation team members.
• Lead test execution according to test protocols.
• Provide support for development of standard operating procedures and other documentation required to go-Live.
• Monitor execution of testing and relay results to technical team to address issues.
• Provide support for training business teams for Go-Live
• Development of training materials as needed
• Provide regular updates to project team

 Qualifications:

• Education/Training: Bachelor’s Degree.
• Experience:
  • Minimum of 5-10 years of experience in IT experience working in the role of business and technical analyst with the focus on data, business intelligence, and analytics projects
  • Experience working in Biotech/Pharma (Regulated Industry)
  • Experience with developing requirements, design, and testing documents.
  • Hands-on experience with data analysis and reporting in support of Pharmaceutical GMP environment.
  • Understanding of GMP data sources across pharmaceutical manufacturing process and quality control testing environment sources such as Laboratory Management Information Systems, Quality Systems, Manufacturing Execution Systems, Data Historian, and other tools.
  • Experience with design and development and usage of data repository and analytics platforms
  • Demonstrated experience managing lifecycle documentation and validation in FDA-regulated environments.
  • Versed in FDA/Industry regulations and policies (Part 11, Computer System Validation)
  • Experience with system administration responsibilities
  • Experience with helping lead data analysis and engineering projects
  • Ability to work under tight timelines
  • Ability to communicate and work across teams in collaborative manner
  • Ability to work independently with minimal supervision

• Knowledge:
  • GxP, Pharmaceutical Manufacturing and Quality Data (GMP data), Data analysis and reporting
  • Understanding of data modeling tools
  • Experience working with analytics (Python, R, Excel, Tableau, Spotfire, other reporting and analytics for manufacturing process industries)
  • Experience with database (SQL) and ETL development
  • Experience with cloud environments (AWS, Azure)
  • Experience with usage of process analytic software is a plus (Aveva, Seeq).
• Skills:
  • System Support/System Administration, Communications, Project Management, Training, Computer System Validation, Business Requirements Documentation.
• Certifications/Licenses: None

Position Summary: 

 We are seeking a highly skilled and motivated Contract Scientist – Translational Biology to support mechanistic hypothesis testing and sample generation for rilparencel, our autologous kidney cell therapy currently being evaluated in a Phase 3 clinical study, as well as next-generation cell therapy programs. This role will focus on primary human tissue/cell culture models (BSL-2) and the execution of multi-condition studies that generate high-quality samples for downstream molecular and NGS-based readouts. In partnership with the Translational Biology team, this scientist will contribute to experimental design and method development for workflows involving small human biopsy-derived samples, with an emphasis on reproducible execution, rigorous sample tracking, and clear communication of results.  

Essential Duties & Responsibilities: 

Primary Human Tissue Culture (BSL-2) & Model Execution 

• Establish, maintain, and troubleshoot primary human kidney tissue/cell cultures using strict aseptic technique and contamination prevention. 

Experimental Design & Method Development  

• Develop and execute experimental plans with the translational team to test mechanistic hypotheses in vitro (e.g., media perturbations, multi-factor time courses), including appropriate controls and replicates. 

• Contribute to method development/optimization for primary tissue workflows (e.g., tissue handling, digestion/single-cell prep where applicable, culture conditions, sampling strategy, preservation), documenting protocol iterations and outcomes. 

• Execute complex study layouts with many conditions, timepoints, replicates, etc when required. 

Sample Processing & Molecular Assays 

• Harvest tissue/cells and perform RNA/DNA/protein/metabolite extraction, quantification, and basic QC (e.g., yield, purity; integrity checks where applicable). 

• Run and troubleshoot core molecular assays, such as RT-qPCR, ELISA, Western blot, and/or reporter assays (e.g., luciferase), including control selection. 

• Prepare assay- and omics-ready sample sets with complete metadata for internal use and/or external partners, as needed. 

NGS Library Preparation & Omics Support 

• Perform NGS library preparation for approaches such as RNA-seq, ATAC-seq, and CITE-seq (bulk and/or 10x single-cell), including essential QC steps (quantification, sizing where applicable, yield assessment). 

• Support handoff of libraries/samples to sequencing vendor pipelines, maintaining traceability of sample IDs, library indices, and processing conditions. 

Documentation & Communication 

• Maintain high-quality experiment documentation (ELN) and accurate sample inventories (LIMS). 

• Participate in interpretation translational data to uncover key insights for cell therapy mechanism of action elucidation. 

• Communicate findings effectively across cross-functional teams, including research, process & analytical development, and clinical translation groups. 

• Contribute to regulatory filings, scientific publications, and presentations at key industry and academic conferences. 

 Qualifications: 

Education/Training 

• M.S. or Ph.D. in Cell Biology, Molecular Biology, Immunology, Bioengineering, or related field.  

Required Experience & Skills 

• Demonstrated hands-on experience with primary human tissue/cell culture and comfort working with human-derived materials in a BSL-2 environment. 

• Experience executing multi-condition in vitro experiments with strong attention to detail and sample tracking. 

• Experience with RNA/DNA/protein extraction and basic QC/quantification. 

• Experience with at least two of: qPCR/RT-qPCR, ELISA, Western blot, reporter assays. 

• Hands-on experience with NGS library preparation for one or more of: RNA-seq, ATAC-seq, CITE-seq (bulk and/or single-cell). 

• Able to work effectively in a fast-moving R&D environment with multiple parallel experiments and time-sensitive sample processing needs. 

Preferred 

• Flow cytometry and/or FACS experience (sample prep, staining, acquisition and/or sorting workflows). 

• Familiarity with common bioinformatics/QC concepts and tools used in sequencing workflows; familiarity with at least one scripting language (Python and/or R). 

Skills:  

• Ability to work in a fast-paced environment and collaborate across disciplines 

• Strong team player 

• Goal-oriented mindset 

• Ability to focus efforts & complete deliverables on-time 

• Certifications/Licenses: Licenses / Certification welcome 

Position Summary:
The Senior Contracts Attorney will play a key role in managing and negotiating a broad range of agreements supporting all aspects of business operations. This position requires strong expertise in contract law, preferably with experience at a public life sciences company. The successful candidate will demonstrate exceptional organizational skills, the ability to manage multiple priorities, and have a proactive approach to problem-solving and stakeholder engagement.

Responsibilities:

• Draft, review, negotiate, and manage a wide variety of contracts, including but not limited to CDAs, consulting agreements, master service agreements, vendor agreements, real estate contracts, clinical trial related contracts and research collaborations.
• Serve as a subject matter expert on contract matters and processes and provide guidance to internal stakeholders.
• Collaborate with cross-functional teams (Clinical Operations, Finance, Procurement, HR, Manufacturing, Research) to ensure compliance and efficiency in contract execution.
• Develop and maintain standardized templates and processes for contract management.
• Provide training and support to business units on contract requirements and approval workflows.
• Advise stakeholders on contractual rights, obligations, and risk mitigation strategies.
• Identify and resolve issues impacting timely completion of contracts.
• Utilize e-signature platforms and ensure proper document finalization and execution.

 Qualifications:

• Juris Doctor (J.D.) from an accredited law school.
• Minimum of 5 years of experience drafting, negotiating, and managing contracts, preferably in a public life sciences company.
  • Experience in a law firm and/or in-house legal department required.
• Comprehensive understanding of contract law and working knowledge of drug development or commercialization a plus.
• Exceptional negotiation, drafting, and analytical skills.
  • Strong organizational and time-management abilities; capable of handling multiple projects under tight deadlines.
  • Excellent interpersonal and communication skills with a customer-service mindset.
  • Ability to work independently and collaboratively in a fast-paced environment.
• Admission to the bar in at least one U.S. state.

Position Summary:

As an Sr. Manager, Process Excellence, you will play a strategic role in driving efficiency, compliance, and transformation within Operational Excellence. You will guide cross-functional teams across manufacturing operations, fostering a culture of innovation, continuous improvement, and operational excellence. Leveraging your expertise in GMP compliance, process improvement methodologies, and digital manufacturing technologies, you will elevate manufacturing performance and drive strategic initiatives.

Responsibilities:

• Develop and implement innovative process improvement strategies, leveraging digital technologies and GMP best practices to enhance efficiency and compliance.
• Collaborate with cross-functional teams to assess and execute strategies that enhance process efficiency, reduce costs, and improve overall performance, align to organizational objectives.
• Develop and maintain comprehensive process documentation (SOPs, process maps, work instructions, RACI).
• Lead change management initiatives to support adoption of new processes and technologies.
• Stay current on industry advancements, best practices, and emerging trends in manufacturing operations management.
• Proactively identify opportunities for optimization, cost reduction, and value creation.
• Identify opportunities for digital transformation within manufacturing operations (automation, data analytics, and tool integration).
• Utilize data analytics and KPIs to monitor performance and identify trends, compliance issues, and improvement opportunities.
• Produce clear reports and insights for senior leadership to inform strategic decisions and provide visibility into manufacturing performance.
• Communicate effectively at all levels, translating complex concepts and strategies into actionable objectives.
• Foster a culture of openness, transparency, and collaboration across manufacturing operations.

Qualifications:

• Bachelor’s degree in Operations Management, Engineering, Life Sciences, or related field. Master’s degree or relevant certifications (e.g., Lean Six Sigma, PMP, CQE) preferred.
• Minimum of 5 years of experience in manufacturing operations management, GMP compliance, process improvement, or related roles in a regulated environment.
• Strong knowledge of GMP regulations and regulatory compliance requirements.
• Expertise in Operational Excellence and continuous improvement methodologies (Lean, Six Sigma, VSM, DMAIC).
• Proficient in process documentation, mapping, and RACI frameworks (SOPs, WI).
• Familiarity with autologous aseptic manufacturing and cleanroom operations.
• Proficiency with manufacturing digital technologies (ERP, MES, LIMS) and process analytics tools (Excel, Visio, data visualization software).
• Knowledge of Chain of Identity/Chain of Custody is a plus.
• Track record of inspection readiness and remediation is a plus.
• Strong analytical, strategic thinking, and change management skills.
• Executive presence with excellent communication skills across all organizational levels.