Supervisor, Reprogramming (iPSC)

Responsibilities

• Lead and participate in day-to-day activities of Manufacturing Associates and ensure adequate resources are available to meet production targets.
• Ensure operations follow phase-appropriate GMP principles, established procedures, and applicable OSHA and Unither safety policies, and promote a strong culture of safety.
• Manage safety incidents, deviations, and non-conformances, including documenting and investigating events in accordance with established procedures.
• Serve as the primary escalation point and key decision-maker for production floor operations, ensuring continuity, product quality, and efficiency.
• Exercise independent judgment on critical operational matters, including adjusting production schedules, responding to unexpected disruptions, and determining whether to proceed under non-ideal conditions in line with GMP principles and established procedures.
• Perform hands-on manufacturing operations alongside Manufacturing Associates in a phase-appropriate GMP environment, including equipment setup and operation, iPSC reprogramming, culture, expansion, scale-up, and cell banking, material preparation, and in-process testing, while maintaining aseptic technique and good documentation practices.
• Review and approve manufacturing documentation, including batch records, deviations, investigations, and corrective actions.
• Create, review, and revise SOPs and manufacturing procedures to reflect current practices and regulatory expectations.
• Monitor, respond to, and lead resolution of all area equipment alarms and alerts on a 24/7 basis; determine appropriate actions as needed for unexpected system interruptions.
• Lead troubleshooting efforts for equipment, systems, and processes; and evaluate product status to determine next steps during process disruptions.
• Initiate and support investigations into process deviations, equipment issues, and operational events; ensure timely resolution and escalation to management as appropriate.
• Proactively plan and adjust schedules to maintain production targets.
• Participate in short-term and long-term planning, including process scale-up, production ramp-up, tech transfer activities, and operational readiness initiatives.
• Collaborate with the procurement team to monitor raw material usage rates, maintain accurate inventory levels, and ensure compliance with the operating budget.
• Support implementation, qualification, and validation of new equipment and/or upgrades; assist with equipment troubleshooting and optimization; contribute to vendor evaluations and outsourcing strategies, providing input on operational feasibility and process impact.
• Conduct performance evaluations, set objectives, and support career development through coaching, mentoring, and development plans; deliver and document on-the-job training for new and current staff on production processes, equipment, and safety procedures; foster a collaborative and accountable team environment.
• Perform additional responsibilities as assigned by leadership.

Minimum Requirements

• Bachelor’s degree in a directly related life science specialty field.
• 5+ years of hands-on experience with cell culture and expansion in 2D and 3D systems (including T-flasks, multi-well plates, and bioreactors).
• Hands-on experience operating cell manufacturing equipment, including automated and closed-system processing platforms, cell separation and culture systems, and standard aseptic processing equipment (e.g., biosafety cabinets, centrifuges, tube welders and sealers).
• Experience with aseptic technique (open vessel/closed systems), cleanroom practices, and contamination control.
• Understanding of basic cell therapy techniques, including cell isolation, transduction, expansion (2D and 3D format).
• Ability to work in a regulated cleanroom environment, including extended periods in full gowning.
• Applied knowledge of pharmaceutical GMPs, FDA guidelines, and industry standards. Ability to apply GMP to company specific processes and products.
• Identify and perform advanced trouble-shooting and assist with technical issues.
• Excellent professional documentation and verbal communication skills. Ability to objectively, accurately, and thoroughly convey complex issues in writing. Ability to produce a large volume of written materials independently.
• Ability to interact with other departments effectively.
• Ability to review work performed by other personnel, communicate problems and deficiencies, elicit corrections, and enforce departmental and Company policy and procedures as they relate to manufacturing requirements.
• Ability to work a rotating schedule that includes weekends and holidays to support routine cell culture activities (e.g., feeding and monitoring), as well as flexible hours and off-shift support to respond to unplanned manufacturing needs.
• Ability to effectively manage a diverse group of skilled manufacturing associates.

Preferred Qualifications

• 5+ years of GMP experience.
• 1+ years of direct supervisory experience.
• Hands-on experience with iPSC reprogramming, culture, characterization, banking, and scale-up to 3D/bioreactor systems.
• Basic understanding of quality control, in process checks (e.g., viability, flow cytometry, qPCR, endotoxin).