Supervisor, Differentiation (iPSC)

United Therapeutics Corporation•Silver Spring, MD

2d•$38 - $50•Onsite

About The Position

The Supervisor, Differentiation (iPSC) is a hands-on leader who guides Manufacturing Associates and participates in iPSC differentiation activities in a phase-appropriate GMP environment. The role combines day-to-day people leadership with direct manufacturing work to support efficient, safe, compliant operations and high-quality production. The supervisor leads production-floor operations, allocates resources, maintains production schedules, and serves as the primary escalation point for operational decisions and disruptions. The role performs manufacturing tasks including equipment setup and operation, iPSC culture and directed differentiation, harvesting and cryopreservation, material preparation, and in-process testing. It also oversees documentation, investigations, procedures, equipment readiness, inventory, and staff development. This 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, 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 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 2D and 3D expansion.
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, review others’ work, communicate problems and deficiencies, elicit corrections, and enforce manufacturing-related 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 stem cell differentiation, such as iPSCs.
Basic understanding of quality control and in-process checks, such as viability, flow cytometry, qPCR, and endotoxin.

Responsibilities

Lead and participate in Manufacturing Associates’ day-to-day activities and ensure adequate 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, exercising independent judgment on schedules, disruptions, and whether to proceed under non-ideal conditions in accordance with GMP principles and procedures.
Perform hands-on manufacturing operations, 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 and respond to area equipment alarms and alerts on a 24/7 basis; determine appropriate actions for unexpected system interruptions.
Lead troubleshooting 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.
Plan and adjust schedules to maintain production targets; participate in short- and long-term planning, production ramp-up, tech transfer, and operational readiness initiatives.
Collaborate with procurement to monitor raw material usage, maintain accurate inventory, and ensure compliance with the operating budget.
Support implementation, qualification, and validation of new equipment and upgrades; assist with troubleshooting and optimization; contribute to vendor evaluations and outsourcing strategies.
Conduct performance evaluations, set objectives, and support staff development through coaching, mentoring, and development plans.
Deliver and document on-the-job training on production processes, equipment, and safety procedures; foster a collaborative and accountable team environment.
Perform additional responsibilities as assigned by leadership.