The Scientific Expert / Senior Scientific Expert, Quality Control (Ancillary Materials and Excipients; Critical Reagents and Reference Standards) will collaborate with the Century’s Research, Technology and Development teams in order to harness the power of adult stem cells to develop curative therapies for cancer. The incumbent’s key responsibilities will be characterization, release, and management of ancillary/raw materials, excipients, critical reagents, and reference standards associated with cell therapy product manufacture and testing. They will also support the drafting of regulatory submissions. This role will require extensive interaction with internal and external partners to leverage best-in-class expertise and capabilities in cell therapy manufacture.
Responsibilities: • This individual will be responsible for establishing the source, identity, purity, biological safety and general suitability of ancillary/raw materials and excipients, as well as characterizing and qualifying critical reagents and reference standards • This includes reagents such as media, sera, cryoprotectants, growth factors, cytokines, and antibodies, as well as product-contact components such as bags, tubing, flasks, and other disposables • The role will interface with internal teams and external partners to perform material and component risk assessments, support vendor/supplier qualification, manage inventories, and develop alternate sourcing strategies, as applicable • Additional responsibilities will include participation on portfolio project teams as project lead and/or functional area expert • Travel up to 25%
Qualifications: • Ph.D. or M.S. in Biochemistry, Bioanalytics, or related life-sciences field • +4 years (Ph.D.) /+8 years (M.S.) experience in a biologics or cell therapeutics development organization, with a thorough knowledge of the development process • Expertise in cell therapeutic quality control methods development, validation, and implementation • Experience with iPSCs or related cell therapy products is preferred • Experience supporting regulatory submissions is desired
Requirements: • Strong expertise in development, validation, and implementation of cell-based assays, flow cytometry, PCR, protein/vector assays, microarrays / MSD, ELISA, and microbiological testing for product quality control • Robust working knowledge of cell therapy products and their associated regulatory standards, as well as related biotechnology products, ancillary materials, excipients, and reagents required for GMP manufacturing • Experience managing relationships with external partners and suppliers • Demonstrated ability to positively influence corporate culture, team dynamics, and influence scientific rigor and productivity
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/