Supervisor, Reprogramming (iPSC)

United Therapeutics Corporation•Silver Spring, MD

2d•$38 - $50•Onsite

About The Position

United Therapeutics is hiring a Supervisor, Reprogramming (iPSC) to lead a team of Manufacturing Associates and work hands-on reprogramming and scaling induced pluripotent stem cells in a phase-appropriate GMP environment. The supervisor sets the pace for safe, compliant, and efficient daily operations, ensuring work follows GMP principles, established procedures, and applicable safety protocols. This role combines technical manufacturing expertise with people leadership to support robust, scalable iPSC manufacturing processes. The supervisor leads and participates in production activities, serves as the primary escalation point for production-floor operations, and exercises independent judgment on operational matters such as schedule adjustments, disruptions, and decisions about proceeding under non-ideal conditions. Hands-on work includes equipment setup and operation, iPSC reprogramming, culture, expansion, scale-up and cell banking, material preparation, and in-process testing. The role also oversees documentation, investigations, equipment and process troubleshooting, production planning, inventory coordination, equipment qualification and validation, and staff training and development. The position is 100% onsite at United Therapeutics’ Silver Spring, Maryland office. It requires a rotating schedule that includes weekends and holidays, as well as flexible hours and off-shift support for unplanned manufacturing needs. The stated compensation 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; ability to objectively, accurately, and thoroughly convey complex issues in writing and independently produce a large volume of written materials.
Ability to interact effectively with other departments, review work performed by other personnel, communicate problems and deficiencies, elicit corrections, and enforce applicable departmental and company policies and procedures.
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 work of Manufacturing Associates and ensure resources are available to meet production targets.
Ensure operations follow phase-appropriate GMP principles, established procedures, and applicable OSHA and company safety policies; promote a strong safety culture.
Manage safety incidents, deviations, and non-conformances, including documenting and investigating events.
Serve as the primary escalation point and key decision-maker for production-floor operations, maintaining continuity, product quality, and efficiency.
Exercise independent judgment on operational matters, including schedule adjustments, unexpected disruptions, and whether to 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, 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 area equipment alarms and alerts on a 24/7 basis; determine appropriate actions for unexpected system interruptions.
Lead troubleshooting of equipment, systems, and processes, and evaluate product status during process disruptions.
Initiate and support investigations into process deviations, equipment issues, and operational events; ensure timely resolution and escalation to management as appropriate.
Plan and adjust schedules to maintain production targets; participate in short- and long-term planning for scale-up, production ramp-up, tech transfer, and operational readiness.
Collaborate with procurement to monitor raw-material usage, maintain inventory levels, and ensure compliance with the operating budget.
Support implementation, qualification, and validation of new equipment and upgrades; assist with troubleshooting and optimization and contribute to vendor evaluations and outsourcing strategies.
Conduct performance evaluations, set objectives, and support employee development through coaching, mentoring, and development plans.
Deliver and document on-the-job training for staff on production processes, equipment, and safety procedures; foster a collaborative and accountable team environment.
Perform additional responsibilities as assigned by leadership.