Senior Biomanufacturing Associate, Recellularization Production

Senior Biomanufacturing Associate, 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 new GMP manufacturing facility focused on tissue engineering and biomanufacturing, the Senior Biomanufacturing Associate, Recellularization Production will lead and execute advanced activities related to the production of recellularized lungs for in vitro and in vivo studies. This position plays an important role in transferring processes from R&D to GMP production readiness and ensuring compliance with established standards. The Senior Associate will act as a subject matter expert for production operations, provide technical support, and guide the implementation of best practices while mentoring junior team members. This role offers hands-on involvement in all aspects of establishing a new GMP manufacturing operation.

• Operate bioprocess equipment and perform production processes in strict compliance with cGMP, OSHA, and United Therapeutics (Unither) policies and regulations
• Serve as SME, or go to operations expert in all production operations, including operation of equipment and process, to support recellularized lung production activities
• Write area SOPs and production batch records
• Monitor and audit work processes to ensure compliance and completion of target
• Gather and analyze information to lead resolution of production problems with minimal guidance.
• Lead closure of process deviations, investigations and corrective actions
• Recommend improvements to existing processes and solutions to improve the efficiency of the team. Contribute to the development of methods and procedures on new assignments.
• Train junior team members on operations of all equipment and processes. Train the team on newly developed improvements and solutions.
• Prepare lung scaffolds and reagents for recellularization, including media preparation, cannulation, loading scaffolds into bioreactor chambers, preparing cell suspensions, and assembling tubing circuits
• Oversee recellularization bioreactor systems by monitoring system 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
• Present data and process updates in internal team meetings as needed

Minimum Requirements

• Bachelor's degree in biology, biotechnology, biomedical engineering, or a related scientific discipline
• 4+ years of experience working with primary cell culture and expansion, hands on experience with bioreactor systems or
• Direct and extensive experience with primary cell culture and expansion
• Proven, hands-on experience with bioreactor systems used in tissue engineering
• Demonstrated expertise in aseptic technique
• Proven ability to lead manufacturing campaigns with minimal supervision
• Strong troubleshooting skills. Experience with process optimization
• Demonstrated ability to work effectively both independently and as part of a team in a collaborative environment
• Proficiency with Microsoft Office applications (or equivalent software) and strong general computer skills
• Strong attention to detail and adherence to Good Documentation Practices (GDP)
• Strong documentation skills with experience authoring SOPs, MBRs, deviation reports
• Excellent verbal and written communication skills
• Ability to work flexible schedules, including shifts, to support 24/7 operations as needed
• Proven proficiency in tissue handling, and aseptic technique

Preferred Qualifications

• 2+ years experience in a cGMP (current Good Manufacturing Practices) biomanufacturing, cell culture, or tissue engineering environment

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.