What are the responsibilities and job description for the Bioprocess Engineer/Senior Bioprocess Engineer - Cell Production & Process Development position at United Therapeutics Corporation?
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 The Bioprocess Engineer, Cell Production and Process Development (OMG) will be responsible for the execution of studies related to the scale up and process development of robust methods to produce iPS-derived autologous cells for 3D printed organs in a GMP setting. Additionally, this role will contribute to supplying primary and iPSC-derived cells for R&D tissue engineering efforts. Execute process development studies to scale-up iPSC differentiation processes to multiple cell types and develop robust, cGMP manufacturing processes Contribute to the production effort to provide sufficient cells for R&D cellularization and tissue engineering efforts of 3D printed scaffolds Assist in developing, writing, and reviewing laboratory methods and protocols Assist in evaluating new technologies for future process development Support tech transfer activities from outside collaborators to internal laboratory and from internal PD efforts to cGMP manufacturing sites, as needed Support the evaluation of laboratory equipment Foster and leverage synergistic interactions with other sub-groups in Organ Manufacturing (e.g., Bioink, Scaffold Production, Cellularization), as needed Support the creation of data for scientific publications and presentations at scientific conferences Additional responsibilities for Senior Bioprocess Engineer, Cell Production and Process Development: Design process development studies to scale-up iPSC differentiation processes to multiple cell types and develop robust, cGMP manufacturing processes Plan production efforts to provide sufficient cells for R&D cellularization and tissue engineering efforts of 3D printed scaffolds Contribute to tech transfer activities from outside collaborators to internal laboratory and from internal PD efforts to cGMP manufacturing sites Work with manufacturing and quality teams to ensure process and methods for production of iPS-derived cells are GMP ready Develop, write, and review laboratory methods and protocols Evaluate new technologies for future process development and participate in the selection, purchase, and implementation of laboratory equipment Author and contribute to scientific publications and present data at scientific conferences Minimum Requirements for the Bioprocess Engineer: Bachelor’s Degree in biomedical science, cell biology or related field or 2 years of relevant industry experience with prior experience in stem cell therapy, bioreactor cell production scale up, regenerative medicine, tissue engineering with a BA/BS Degree or 1 years of relevant industry experience in stem cell biology, bioreactor cell production scale up, regenerative medicine, tissue engineering with a Master's Degree Strong working knowledge of cellular process development Experience with cell bioreactor culture, preferably Sartorius Ambr/B-DCU systems and/or vertical wheel bioreactors with scales up to 10L Experience with automated cell processing equipment such CliniMACS Plus, LOVO, Cue, Sepax, Sefia, Rotea or others Knowledge in transfer of R&D cell expansion methods to GMP Proficient with appropriate word processing, spreadsheet, presentation and related standard software; Experience with laboratory instrumentation and data software Ability to accommodate a non-traditional work schedule (e.g. Sun-Thu, Tue-Sat) Minimum Requirements for the Senior Bioprocess Engineer: Bachelor’s Degree in biomedical science, cell biology or related field or 5 years of relevant industry experience with prior experience in stem cell therapy, bioreactor cell production scale up, regenerative medicine, tissue engineering with a BA/BS Degree or 3 years of relevant industry experience in stem cell biology, bioreactor cell production scale up, regenerative medicine, tissue engineering with a Master's Degree Technical expertise in cellular process development Technical expertise in cell bioreactor culture, preferably Sartorius Ambr/B-DCU systems and/or vertical wheel bioreactors with scales up to 10L Expertise in automated cell processing equipment such CliniMACS Plus, LOVO, Cue, Sepax, Sefia, Rotea or others Proficient with appropriate word processing, spreadsheet, presentation and related standard software; Experience with laboratory instrumentation and data software Ability to accommodate a non-traditional work schedule (e.g. Sun-Thu, Tue-Sat) Preferred Qualifications for the Bioprocess/Senior Bioprocess Engineer: Master’s Degree in biomedical science, cell biology or related field Job Location Manchester, New Hampshire 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. We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success. We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work.
