Senior Bioprocess Engineer - Cell Production & Process Development

Job description

California, US residents click here. The job details are as follows: Who We Are 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. Who You Are Imagine telling people your work helps create the building blocks for 3D printed organs. At United Therapeutics, that's not science fiction. It's the mission. We're seeking a driven Bioprocess Engineer to help develop and scale robust cell production processes that support some of the most ambitious advances in regenerative medicine today. You'll join a highly collaborative team where innovation is expected, scientific curiosity is celebrated, and your contributions have the potential to change the future of transplant medicine for patients around the world. 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. At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. 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 United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.