Cell Manufacturing Associate I​/II; iPSC)

Position: Cell Manufacturing Associate I/II (iPSC)
## Cell Manufacturing Associate I/II (iPSC)
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On-Site:
Silver Spring, MD:
Full time:
Posted Yesterday:
R05368

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 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…