Senior Scientist, Process Development at United Therapeutics in Cambridge, MA

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. Thymmune, a United Therapeutics subsidiary is a biotechnology company developing a machine learning-driven thymic cell engineering platform to restore normal immune function in aging and disease. The company's cutting-edge approach in iPSC-thymic cell manufacturing can generate off-the-shelf cells at scale. The company is developing a pipeline of therapies to treat immunodeficiencies, transplant related, and autoimmune diseases. Who You Are At Thymmune, you'll join a team pushing the boundaries of cell therapy and transplant innovation through advanced iPSC-derived manufacturing technologies. As a Senior Scientist, Process Development, you'll play a pivotal role in designing and optimizing processes that support the development of transformative therapies, helping move breakthrough science from concept to clinic. It's an opportunity to solve tough scientific challenges, collaborate with world-class colleagues, and contribute to a future where more patients have access to life-changing treatments The Senior Scientist, Process Development (CMC) will plan, conduct, and support process development activities for an iPSC-derived thymic epithelial progenitor cell process. Activities include scale-up, expansion, differentiation (2D and 3D), harvest, wash, formulation and stability to ensure process reproducibility and robustness. Design, lead, and optimize iPSC expansion, differentiation, and scale-up processes to improve process robustness, reproducibility, and product quality Design and execute development strategies for harvest, downstream processing, formulation, fill-finish, and fresh/cryopreservation processes to support clinical and commercial manufacturing needs Lead process characterization studies and author technical documentation to support technology transfer, process validation, and GMP manufacturing readiness Collaborate cross-functionally with Analytical Development and other technical teams to define critical process attributes, characterize process performance, and advance process understanding Design and conduct complex studies to develop and optimize biomaterial-based cell delivery approaches, formulation strategies, and clinical in-use hold times Contribute substantively to FDA and other regulatory submissions by authoring and reviewing technical reports, process development summaries, protocols, risk assessments, and CMC documentation supporting product development and clinical advancement Analyze, interpret, and communicate experimental results to project teams and leader