Century Therapeutics is harnessing the power of adult stem cells to develop allogeneic cancer therapies. The Scientific Expert or Senior Scientific Expert will utilize their experience and knowledge to design and execute R&D activities focused on mammalian cell culture technologies, with a focus on cell physiology and process scale-up. Key responsibilities include, but are not limited to, the development, characterization/validation, and transfer of cell manufacturing processes (including ancillary materials and product formulation/storage) to GMP facilities. The ideal candidate will serve as a subject matter expert, design and execute lab experiments toward manufacturing process optimization, provide operational support, draft regulatory submissions, and interact effectively with internal and external stakeholders. Our expectation is that the incumbent will progress to take on team leadership responsibilities as the Process Development function grows over the next 1-2 years.
Responsibilities: • Develop and implement manufacturing processes capable of supplying clinical trials with material complying to product quality targets, current Good Manufacturing Practices (cGMP), and regulatory requirements • Support the delivery of engineered immune cell therapies e.g., draft regulatory submissions, serve as a functional representative on project teams. Sr. Scientific Expert or Associate Director: Responsible for development and strategic direction of novel portfolio assets e.g., lead project teams • Identify novel solutions to address key technical challenges required for manufacturing platform success, such as cell culture media optimization, process engineering, cryo-preservation, etc. • Outline experimental strategy toward at-scale cell differentiation, expansion and formulation capabilities • Collaborate with external partners to integrate stem cell process technology and optimize Century’s next-generation manufacturing process • Define the scientific agenda and manage research activities of junior lab members and interns/co-ops • Maintain laboratory procedures, systems, and notebooks, to ensure documentation of research activities • Travel up to 25%
Qualifications: • Proven track record in bioprocess development, e.g. therapeutic proteins, vaccines and/or cellular therapies • Extensive experience with mammalian cell culture media optimization, process scale-up/down, characterization, product formulation, technology transfer • Understanding of cell biology/physiology and/or engineering fundamentals. Experience with induced pluripotent stem cells (iPSC) is highly desirable • Equipment development and qualification in cGMP environment e.g., IQ/OQ/PQ • Experience with regulatory submissions e.g., IND, BLA • Dynamic and culturally astute team-player, scientifically rigorous with excellent communication skills
Requirements: • PhD in biochemistry, biochemical engineering, or related field with 4 years of relevant experience, or MS with 8 years of relevant experience • Functional experience in mammalian cell culture process development, including molecular biology, aseptic techniques, and cryo-preservation • Understanding of bioprocess characterization/validation concepts, cGxPs, and CMC regulatory requirements • Sr. Scientific Expert or Associate Director: Ability to manage and deliver high-profile projects
About Century Therapeutics, LLC:
Century Therapeutics is developing novel allogeneic living cell products for oncology that overcome the limitations of first-generation cell therapies. Our genetically-engineered, universal iPSCs-derived immune effector cell products (NK, T, Dendritic cells, and macrophages) are designed to specifically target hematologic and solid tumor cancers. Our commitment to developing off-the-shelf cell therapies will expand patient access and provides an unparalleled opportunity to advance the course of cancer care. https://www.centurytx.com/