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The job details are as follows:
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 escalate 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
