Senior Cell Manufacturing Associate (iPSC)

United Therapeutics Corporation; Silver Spring (MD); On-site; USD 50,000 - 60,000; Full time

Job summary

United Therapeutics Corporation seeks a Senior Cell Manufacturing Associate to join the Cell Manufacturing team in Silver Spring, MD. You will execute end-to-end iPSC manufacturing and support technology transfer, troubleshooting, documentation, and mentorship in a regulated startup environment.

This hands-on role requires strong GMP discipline, cell culture expertise, and the ability to lead others during production, quality checks, and equipment setup while maintaining cGMP training and

Qualifications

• Bachelor’s degree in biology, cell and molecular biology, biomanufacturing, or related field.
• 4+ years hands-on experience with culture vessel types (T-flasks, Hyperflasks, etc.).
• Experience with aseptic technique, cleanroom practices, and GDP.
• Understanding of cell therapy techniques (isolation, expansion, differentiation).
• Knowledge of cGMP regulations and good documentation practices.

Responsibilities

• Perform hands-on manufacturing operations in a GMP environment.
• Set up and operate cell manufacturing equipment.
• Lead work of others as a team leader.
• Maintain aseptic technique and documentation practices.
• Support investigations into process deviations and equipment issues.

Skills

Cell culture

GMP

Documentation

Root cause analysis

Education

Bachelor’s degree in biology or related field

Tools

Biosafety cabinets

Centrifuges

Bioreactors

Job description

California, US residents

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

Join our Cell Manufacturing team as a Senior Cell Manufacturing Associate and play a key role in the startup and operation of induced pluripotent stem cell (iPSC) manufacturing. As part of the Differentiation or Reprogramming team, you will execute end‑to‑end cell manufacturing processes in a regulated environment while helping establish the processes, procedures, and capabilities needed for successful production. This is a hands‑on role for someone who can bring strong technical expertise to daily manufacturing operations while also serving as a go‑to resource for the team, supporting technology transfer, troubleshooting, documentation, and the training and mentoring of colleagues.

• Perform hands‑on manufacturing operations 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
• Set up and operate cell manufacturing equipment used for cell production
• Perform cell manufacturing processes such as cell culture, expansion according to established procedures, while identifying opportunities for refinement
• Prepare required raw materials, vessels, assemblies, media, tools, and samples
• Serve as go to operations expert in all production operations, often acting as a team leader, coordinating and leading the work of others
• Perform cleaning and sanitization of cleanroom environment and equipment
• Set up and run analytical tests and/or in‑process checks to confirm compliance with quality standards, and elevate deviations appropriately
• Perform moderate complexity trouble‑shooting and assisting with technical issues and problems, including root cause analysis
• Perform good documentation practices on batch records and logbooks and support document review and revision cycles
• Initiate and support investigations into process deviations, equipment issues, and operational events
• Author and review production documentation (e.g., SOPs, production records), and support updates based on process changes
• Maintain personal cGMP training to ensure compliance, and assist in training and mentoring junior team members
• Conduct routine inventory of raw materials/consumables used in production and assist with procurement activities
• Participate in a 24/7 rotation on‑call schedule to acknowledge manufacturing equipment alarms
• All other duties as required

Minimum Requirements

• Bachelor’s degree in biology, cell and molecular biology, biomanufacturing, or a related field
• 4+ years of hands‑on experience with multiple culture vessel types, 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 and differentiation (2D and 3D format)
• Knowledge of cGMP regulations and Good Documentation Practices (GDP)
• Ability to document work accurately in batch records and logbooks and follow standard operating procedures
• Ability to work in a regulated cleanroom environment, including extended periods in full gowning
• Capacity to learn new techniques quickly and contribute to process improvements
• Ability to work effectively in an ambiguous and fast‑changing environment typical of manufacturing startup activities, adapting to evolving processes, priorities, and 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
• Interpret data, perform basic mathematical calculations (e.g., dimensional analysis, molarity, seeding calculations, dilutions, etc.)

Preferred Qualifications

• Hands‑on experience with stem cell differentiation (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 $36.06 - $43.27/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.