Cell Manufacturing Associate I/II - 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

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 induced pluripotent stem cell (iPSC) manufacturing processes, helping to establish a robust manufacturing platform capable of delivering high-quality cell therapy products. This is a unique opportunity to contribute to the build-out of manufacturing operations, support process implementation, and work in a highly collaborative, GMP-regulated environment where scientific excellence, quality, and continuous improvement are key priorities.

• 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
• All other duties as required

Minimum Requirements

• Education and Experience for Cell Manufacturing Associate I
  • 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, etc.)
• Education and Experience for Cell Manufacturing Associate II
• Bachelor’s Degree in biology, cell and molecular biology, biomedical sciences, biomedical engineering, biomanufacturing, or a related field
  • 2+ years of relevant experience in biology, cell and molecular biology, biomedical sciences, biomedical engineering, biomanufacturing, regenerative medicine, or a related field and
• 2+ years of hands-on experience with multiple culture vessel types, including T-flasks, multi-well plates, Hyperflasks, CellSTACKs and bioreactors.
• 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, 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 feeding and monitoring), as well as flexible hours and off-shift support to respond to unplanned manufacturing needs
• Interpret data, and be able to perform basic mathematical calculations (e.g., dimensional analysis, molarity, seeding calculations, serial dilutions etc.)

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)

Job Location

United Therapeutics requires this role to be 100% onsite in our Silver Spring, MD office.

The salary range for Cell Manufacturing Associate I is $30.05-$32.21/hour and reflects our good-faith estimate of the compensation for this role at the time of posting. The salary range for the Cell Manufacturing Associate II is $32.21 - $36.06/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.