Cell Manufacturing Associate I/II (iPSC)
United Therapeutics Corporation
Summary
Join a dynamic and innovative team at the forefront of induced pluripotent stem cell (iPSC) manufacturing. The Cell Manufacturing Associate I/II will play a vital role in the startup and operation of iPSC manufacturing processes, helping to establish a robust manufacturing platform capable of delivering high-quality cell therapy products.
Job description
Responsibilities
- Perform hands-on manufacturing operations in a phase-appropriate GMP environment, including iPSC expansion, differentiation, harvest and cryopreservation while maintaining aseptic technique and good documentation practices
- Set up and operate cell manufacturing equipment used for cell production (e.g., bioreactors, flask coating/preparation)
- Prepare raw materials, vessels, assemblies, media, tools and samples
- Perform cleaning and sanitization of cleanroom environment and equipment
- Prepare samples for analytical tests and/or in-process checks
- Author and review production documentation (e.g., SOPs, production records), and support updates based on process changes
- Perform good documentation practices on batch records and logbooks and support document review and revision cycles
- Perform basic trouble-shooting and assist with technical issues during manufacturing runs
- Maintain personal cGMP training to ensure compliance
- Participate in a 24/7 rotation on-call schedule to acknowledge manufacturing equipment alarms
Minimum Requirements
- Bachelor's Degree in biology, cell and molecular biology, biomanufacturing, or a related field
- Hands-on experience operating cell manufacturing equipment, including automated and closed-system processing platforms (e.g., biosafety cabinets, centrifuges, tube welders, sealers)
- Experience with aseptic technique, cleanroom practices, and contamination control
- Basic understanding of cell therapy techniques, including cell isolation, transduction, expansion and differentiation
- 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
- Ability to work a rotating schedule that includes weekends and holidays, as well as flexible hours and off-shift support
- Interpret data and perform basic mathematical calculations (e.g., dimensional analysis, molarity, seeding calculations, serial dilutions)
Preferred Qualifications
- 1+ years of hands-on experience handling T-flasks, multi-well plates and benchtop bioreactors
- Knowledge of cGMP regulations and Good Documentation Practices (GDP)
Requirements
- Bachelor's Degree in biology, cell and molecular biology, biomanufacturing, or a related field
- Hands-on experience operating cell manufacturing equipment, including automated and closed-system processing platforms
- Experience with aseptic technique, cleanroom practices, and contamination control
- Basic understanding of cell therapy techniques, including cell isolation, transduction, expansion and differentiation
- 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
- Ability to work a rotating schedule that includes weekends and holidays
- Ability to interpret data and perform basic mathematical calculations
- 1+ years of hands-on experience handling T-flasks, multi-well plates and benchtop bioreactors
- Knowledge of cGMP regulations and Good Documentation Practices (GDP)
Benefits
- Medical, Dental & Vision
- Prescription Coverage
- Employee Wellness Resources
- 401(k) Matching
- Employee Stock Purchase Plan
- Paid Time Off
- Paid Parental Leave
- Disability Benefits
Company overview
United Therapeutics Corporation is an American biotechnology company founded in 1996 with a deeply personal mission: to find a cure for pulmonary arterial hypertension (PAH) after the founder's daughter was diagnosed with this rare disease. Headquartered in Silver Spring, Maryland and Research Triangle Park, North Carolina, the company has evolved into a pioneering force in biotechnology, focusing on developing novel pharmaceutical therapies and technologies that expand the availability of transplantable organs. United Therapeutics specializes in treatments for pulmonary arterial hypertension, pulmonary hypertension associated with interstitial lung disease, neuroblastoma, and end-stage lung disease through its flagship products including Tyvaso, Remodulin, Orenitram, Adcirca, and Unituxin. The company is particularly notable for being the first publicly-traded biotech or pharmaceutical company to convert to a public benefit corporation (PBC), with a dual purpose of developing innovative pharmaceutical therapies and creating technologies that increase transplantable organ availability. Their groundbreaking work includes xenotransplantation research, organ manufacturing technologies, and regenerative medicine programs aimed at addressing critical shortages in transplantable organs. With approximately 1,001-5,000 employees and a strong commitment to corporate social responsibility, United Therapeutics has established itself as a leader in both patient-focused innovation and workplace excellence.