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The job details are as follows: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.
- 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.
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
Minimum 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
Preferred Qualifications
- 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.)
Job Location
This position is located in our Manchester, NH Lab. Flexible hours are necessary.
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. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
