Senior Bioprocess Engineer - Cell Production & Process Development

United Therapeutics Corporation•Manchester, NH

7d•Onsite

About The Position

The Senior Bioprocess Engineer, Cell Production and Process Development (OMG) will be responsible for contributing to the production and supply of primary and iPSC-derived cells, as well as the development, optimization, and scale-up of robust, GMP-compliant manufacturing processes. This role independently leads small-to-medium studies and/or cell production runs, ensuring the consistent delivery of high-quality cellular products for research and clinical applications.

Requirements

Bachelor’s Degree in biomedical science, cell biology or related field or Master’s Degree in biomedical science, cell biology or related field or Doctor of Philosophy (PhD) in biomedical science, cell biology or related field
5+ years of relevant experience in stem cell therapy, bioreactor cell production, scale up, regenerative medicine, tissue engineering with a BA/BS Degree or 3+ years of relevant experience in stem cell therapy, bioreactor cell production, scale up, regenerative medicine, tissue engineering with a Master's Degree or 1+ years of relevant experience in stem cell therapy, bioreactor cell production, scale up, regenerative medicine, tissue engineering with a PhD
Strong background in cellular process development and/or mid-scale cell production (2-10L)
Technical expertise in cell bioreactor culture, preferably Sartorius Ambr/B-DCU systems and/or vertical wheel bioreactors with scales up to 10L+
Proficient with appropriate word processing, spreadsheet, presentation, and related standard software
Experience with laboratory instrumentation and data software
Excellent written and oral communication skills
Strong organizational skills and attention to detail
Ability to accommodate a non-traditional work schedule (e.g. Sun-Thu, Tue-Sat) and/or contribute to Weekend/Holiday work as needed
Previous industry experience

Nice To Haves

Experience with automated cell processing equipment, such as CliniMACS Plus, LOVO, Cue, Sepax, Sefia, Rotea
Knowledgeable in the transfer of R&D cell expansion methods to GMP
Experience with relevant statistical software (GraphPad Prism, MODDE, SIMCA, JMP, etc.)

Responsibilities

Plan and contribute to the execution of cell production runs to provide a reliable supply of primary and iPSC-derived cells for research and process development activities
Independently lead small-to-medium process development studies to develop, optimize, and scale robust, cGMP-compliant manufacturing processes for iPSC-derived cells, including study planning, execution, data analysis, risk identification, and communication of results and recommendations
Develop, author, review, and maintain laboratory procedures, records, technical reports, protocols, and other controlled documentation to support process development, technology transfer, and GMP readiness
Investigate process deviations, troubleshoot technical challenges, and identify opportunities for process improvements that enhance manufacturing robustness, consistency, efficiency, and scalability
Evaluate emerging technologies, equipment, and manufacturing strategies to support continuous improvement initiatives, including participation in the selection, acquisition, implementation, and lifecycle management of laboratory and manufacturing equipment
Foster and leverage synergistic interactions with other sub-groups in Organ Manufacturing (e.g., Analytical Development, Operations, Tissue Engineering, Quality, Manufacturing), as appropriate
Author technical reports, support regulatory and technical documentation, contribute to scientific publications, and present data to internal and external audiences
Perform other duties as assigned