Supervisor, Differentiation (iPSC)

United Therapeutics•Silver Spring, MD

1d•Onsite

About The Position

The Supervisor, Differentiation (iPSC) is a hands-on leader who guides Manufacturing Associates while also carrying out iPSC differentiation activities in a phase-appropriate GMP environment. The role combines day-to-day people leadership with direct participation in manufacturing operations, supporting efficient, safe, compliant execution and operational excellence. The Supervisor leads production-floor operations and serves as the primary escalation point and key decision-maker for operational issues. This includes adjusting schedules, managing unexpected disruptions, evaluating product status, and deciding whether to proceed under non-ideal conditions in accordance with GMP principles and established procedures. The role also oversees safety incidents, deviations, non-conformances, investigations, and corrective actions. The position is 100% onsite in Silver Spring, Maryland. It requires rotating schedules that include weekends and holidays, as well as flexible hours and off-shift support for routine cell culture activities and unplanned manufacturing needs. The listed salary range is $37.98–$50.48 per hour. Eligible employees may participate in the company’s benefits programs.

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 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, to meet routine cell culture 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 testing.

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 follow phase-appropriate GMP principles, established procedures, applicable OSHA requirements, and company safety policies; promote a strong safety culture.
Manage safety incidents, deviations, and non-conformances, including documenting and investigating events according to established procedures.
Serve as the primary escalation point and key decision-maker for production-floor operations, supporting continuity, product quality, and efficiency.
Exercise independent judgment on operational matters, including schedule adjustments, unexpected disruptions, and decisions about proceeding under non-ideal conditions in line with GMP principles and procedures.
Perform hands-on manufacturing activities, 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 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 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 proactively to maintain production targets; participate in short- and long-term planning, production ramp-up, technology transfer, and operational readiness initiatives.
Collaborate with procurement to monitor raw-material usage and maintain accurate inventory levels while ensuring 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 by assessing operational feasibility and process impact.
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.