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The job details are as follows:
Lead from the bench and help advance the next generation of cell-based manufacturing. As Supervisor, Reprogramming (iPSC), you will guide a team of Manufacturing Associates while working alongside them to reprogram and scale induced pluripotent stem cells (iPSCs) in a phase-appropriate GMP environment. You will set the pace for safe, compliant, and efficient day-to-day operations, ensuring work is executed in accordance with GMP principles, established procedures, and safety protocols. This is an opportunity for a hands-on leader to combine technical expertise with people leadership and make a meaningful impact on the development of robust, scalable iPSC manufacturing processes.
- 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 w/equipment troubleshooting & 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)
Job Location
United Therapeutics requires this role to be 100% onsite in our Silver Spring, MD office.
The salary range for this position is $37.98 - $50.48/hour and reflects our good-faith estimate of the compensation for this role at the time of posting. An employee’s position within the salary range will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as well as other factors permitted by law at the time of posting. This range may be modified in the future based on company and market factors.
At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.
Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
