Supervisor, Differentiation (iPSC) - Differentiation, iPSC

California, US residentsclick here.

The job details are as follows:

Who We Are

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.

United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).

The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.

Who You Are

The Supervisor, Differentiation (iPSC) is a hands-on leader who guides a team of Manufacturing Associates while working alongside them to carry out iPSC differentiation activities in a phase-appropriate GMP environment. This role combines day-to-day people leadership with direct participation in manufacturing operations, helping the team execute efficiently, safely, and in accordance with GMP principles and established procedures. The ideal candidate brings strong technical capability, a collaborative leadership style, and a commitment to quality, compliance, and operational excellence.

• 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 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 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 production ramp-up, tech transfer activities, and operational readiness initiatives.
• Collaborate with the procurement team to monitor raw material usage rates and maintain accurate inventory levels and ensure compliance with operating budget
• Support implementation, qualification, and validation of new equipment and/or upgrades; assist with equipment troubleshooting and 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, 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 (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 stem cell differentiation (e.g., iPSCs)
• 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

United Therapeutics  Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.