Manufacturing Operations Supervisor

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)

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.