Biomanufacturing Associate I, Recellularization Production

Biomanufacturing Associate I, Recellularization Production

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.

As part of a start-up, new GMP manufacturing facility focused on tissue engineering and biomanufacturing, the Biomanufacturing Associate I, Recellularization Production will support activities related to the production of recellularized lungs for in vitro and in vivo studies to meet departmental and company objectives. This role provides valuable hands-on experience in all aspects of establishing a new GMP manufacturing operation, including the technical transfer of processes from R&D to production readiness.

• Operate bioprocess equipment and perform production processes in strict compliance with cGMP, OSHA, and United Therapeutics (Unither) policies and regulations
• Work as an integral member of the team to support recellularized lung production activities
• Prepare lung scaffolds and reagents for recellularization, including media preparation, cannulation, loading scaffolds into bioreactor chambers, preparing cell suspensions, and assembling tubing circuits
• Monitor recellularization bioreactor systems parameters (e.g., pressure, flow, timing) and biological indicators (e.g., metabolism, nutrient consumption)
• Accurately and promptly record data in batch records, logbooks, and system documentation in accordance with Good Documentation Practices (GDP)
• Perform in-process and end-of-process sampling and testing
• Conduct routine analyses of in-process measurements and recellularization data
• Perform basic troubleshooting of equipment issues or process deviations
• Draft process deviation reports as required
• Present data and process updates in internal team meetings as needed

Minimum Requirements

• Education and Experience Required for Cell Manufacturing Associate I
• 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
• 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

Preferred Qualifications

• 1+ years experience with aseptic technique, cleanroom practices, and contamination control
• Basic understanding of quality control, in process checks (e.g., viability, sterility, bioburden, endotoxin)
• 1+ years' experience with cell culture or tissue engineering

Job Location & Travel

This is a fully onsite role in our RTP, NC Office. This role may require up to 10% of domestic and international travel.

United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.