Supervisor, Reprogramming (iPSC)

United Therapeutics • Silver Spring, MD

1d • Onsite

About The Position

The Supervisor, Reprogramming (iPSC) leads a team of Manufacturing Associates and works alongside them to reprogram and scale induced pluripotent stem cells (iPSCs) in a phase-appropriate GMP environment. The role sets the pace for safe, compliant, and efficient daily operations and helps develop robust, scalable iPSC manufacturing processes. This position is 100% onsite in United Therapeutics’ Silver Spring, Maryland office.

The supervisor performs hands-on manufacturing activities, oversees production-floor operations, and serves as the primary escalation point and key decision-maker for operational issues. The role includes people leadership, staff training and development, documentation review, investigations, equipment and process troubleshooting, scheduling, inventory and budget coordination, and support for scale-up, technology transfer, equipment qualification, validation, and operational readiness. The position requires rotating schedules that include weekends and holidays, as well as flexible hours and off-shift support for unplanned manufacturing needs. The posted salary range is $37.98–$50.48 per hour.

Requirements

• Bachelor’s degree in a directly related life science specialty field.
• At least 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 such as biosafety cabinets, centrifuges, tube welders, and sealers.
• Experience with aseptic technique in open-vessel and closed systems, cleanroom practices, and contamination control.
• Understanding of basic cell therapy techniques, including cell isolation, transduction, and expansion in 2D and 3D formats.
• Ability to work in a regulated cleanroom environment, including extended periods in full gowning.
• Applied knowledge of pharmaceutical GMPs, FDA guidelines, and industry standards, and ability to apply GMP to company-specific processes and products.
• Ability to identify and perform advanced troubleshooting and assist with technical issues.
• Excellent professional documentation and verbal communication skills, including the ability to convey complex issues objectively, accurately, and thoroughly in writing and independently produce a large volume of written materials.
• Ability to interact effectively with other departments.
• Ability to review others’ work, communicate problems and deficiencies, elicit corrections, and enforce departmental and company policies and procedures related to manufacturing requirements.
• Ability to work a rotating schedule that includes weekends and holidays, as well as flexible hours and off-shift support for routine cell culture activities and unplanned manufacturing needs.
• Ability to effectively manage a diverse group of skilled Manufacturing Associates.

Nice To Haves

• At least 5 years of GMP experience.
• At least 1 year of direct supervisory experience.
• Hands-on experience with iPSC reprogramming, culture, characterization, banking, and scale-up to 3D or bioreactor systems.
• Basic understanding of quality control and in-process checks, such as viability, flow cytometry, qPCR, and endotoxin.

Responsibilities

• Lead and participate in the day-to-day activities of Manufacturing Associates and ensure adequate resources are available to meet production targets.
• Ensure operations comply with phase-appropriate GMP principles, established procedures, OSHA requirements, and company safety policies; promote a strong safety culture.
• Manage safety incidents, deviations, and non-conformances, including documentation and investigation.
• Serve as the primary escalation point and decision-maker for production-floor operations, balancing continuity, product quality, and efficiency.
• Exercise independent judgment on operational matters, including adjusting schedules, responding to disruptions, and deciding whether work can proceed under non-ideal conditions in accordance with GMP principles and procedures.
• Perform hands-on manufacturing work, including equipment setup and operation; iPSC reprogramming, culture, expansion, scale-up, and cell banking; material preparation; and in-process testing.
• Maintain 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 and respond to area equipment alarms and alerts on a 24/7 basis, determine appropriate actions for unexpected system interruptions, and lead troubleshooting of equipment, systems, and processes.
• Evaluate product status and determine next steps during process disruptions.
• Initiate and support investigations into process deviations, equipment issues, and operational events; ensure timely resolution and escalate to management as appropriate.
• Plan and adjust schedules to maintain production targets, and participate in short- and long-term planning for process scale-up, production ramp-up, technology transfer, and operational readiness.
• Collaborate with procurement to monitor raw material usage, maintain accurate inventory, and comply with the operating budget.
• Support implementation, qualification, and validation of new or upgraded equipment; assist with troubleshooting and optimization; and contribute to vendor evaluations and outsourcing strategies.
• Conduct performance evaluations, set objectives, and support staff 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.

Benefits

• Eligible employees may participate in medical, dental, vision, and prescription coverage.
• Employee wellness resources.
• Savings plans, including a 401(k) and an employee stock purchase plan (ESPP).
• Paid time off.
• Paid parental leave benefits.
• Disability benefits.
• Additional company benefits and amenities.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager