iPSC Manufacturing Supervisor – GMP Cell Culture Lead

United Therapeutics Corporation; Silver Spring (MD); On-site; USD 52,000 - 70,000; Full time

Job summary

United Therapeutics Corporation in Silver Spring, MD is seeking a Supervisor, Differentiation (iPSC) to lead Manufacturing Associates in a phase‑appropriate GMP environment. The role combines hands‑on production with people leadership to deliver quality, compliant cell therapies.

The ideal candidate has 5+ years of cell culture experience, GMP know‑how, and proven supervisory ability in a regulated biopharma setting. This onsite role requires flexibility to meet production and schedule needs.

Qualifications

• 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, Hyperflasks, CellSTACKs 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. The 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
• Ability to effectively manage a diverse group of skilled manufacturing associates

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 culture and directed differentiation, harvest and cryopreservation, 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 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 production ramp‑up, tech transfer activities, and operational readiness initiatives.
• Collaborate with the procurement team to monitor raw material usage rates and maintain accurate inventory levels and ensure compliance with 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

Skills

Cell culture

GMP knowledge

People leadership

Regulatory compliance

Documentation

Communication

Problem solving

Aseptic technique

Cross-functional collaboration

Safety leadership

Education

Bachelor’s degree in life science

Tools

Biosafety cabinets

Centrifuges

Tube welders & seals

Automated/closed-system platforms

Bioreactors

Job description

United Therapeutics Corporation in Silver Spring, MD is seeking a Supervisor, Differentiation (iPSC) to lead Manufacturing Associates in a phase‑appropriate GMP environment. The role combines hands‑on production with people leadership to deliver quality, compliant cell therapies.

The ideal candidate has 5+ years of cell culture experience, GMP know‑how, and proven supervisory ability in a regulated biopharma setting. This onsite role requires flexibility to meet production and schedule needs.