Cell Manufacturing Associate I/II (iPSC)

United Therapeutics Corporation • Silver Spring, MD

1d • $30 - $36 • Onsite

About The Position

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. Do you want to be part of cutting-edge science? Join our team in working in the exciting field of iPSC-derived cell therapies! As part of the startup and operation of induced pluripotent stem cell (iPSC) manufacturing, the Associate will join the Cell Manufacturing team and play a key role in establishing and running production activities. This position is responsible for executing end-to-end cell manufacturing processes in a regulated environment, while also contributing to startup activities such as drafting standard operating procedures, supporting technology transfer, and performing experiments using established protocols.

Requirements

• Bachelor’s degree in biology, cell and molecular biology, biomedical sciences, biomedical engineering, biomanufacturing, or a related field
• 0+ years of relevant experience in biology, cell and molecular biology, biomedical sciences, biomedical engineering, biomanufacturing, regenerative medicine, or a related field
• 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
• 1+ years of experience with aseptic technique and cell culture
• Knowledge of cGMP regulations and Good Documentation Practices (GDP)
• Experience operating cell manufacturing equipment like biosafety cabinets, incubators, bioreactors, centrifuges, pipettes, etc
• 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 flexible hours and respond to unplanned manufacturing needs, including potential weekend or off-shift support

Nice To Haves

• Experience with aseptic technique, cleanroom practices, and contamination control
• Basic understanding of quality control, in process checks (e.g., viability, sterility, bioburden, endotoxin)
• Understanding of basic cell therapy techniques, including cell isolation, transduction, and expansion
• Experience with aseptic technique and cell culture

Responsibilities

• Set up and operate cell manufacturing equipment used for cell production
• Perform cell manufacturing processes like cell culture, expansion according to established procedures
• Maintain aseptic technique and operate within a controlled, regulated manufacturing environment
• Prepare required raw materials, assemblies, solutions, tools, and samples
• 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
• Perform good documentation practices on batch records and logbooks
• Contribute to scaling-up, basic trouble-shooting and assisting with technical issues and problems
• Maintain and prepare production documentation (standard operating procedures)
• Maintain personal cGMP training to ensure compliance
• All other duties as required

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 1,001-5,000 employees