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)

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.

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

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.