Research Associates/Scientists, Cell-based product development
(1)Learn and follow in-house differentiation protocols for desired cell types. Consult with members of cross-functional teams on the potential utility of various attribute assays.
(2)Work as part of a team to identify, test, optimize numerous assays for the characterization of in-process, bulk, and final cell-based products.
(3)Set assay specifications, write/edit standard operating procedures with consultation from relevant members of the research, QC, QA, and manufacturing departments.
(4) QC-validate GMP manufactured lots of pipeline products using SOPS and passing or failing them based on the SOP specifications.
(5)Tighten assay specifications with iterative manufacturing runs, after any process changes, or as product advances through various inflexion points during its clinical development. Requirements:
B.S./M.S in biology, biochemistry, immunology or related field. At least 2+ years cell culture experience. Previous experience in one or more of the following areas is a plus: pluripotent stem cell culture, assay development, writing standard operating
procedures, validation, GMP documentation The ability to perform laboratory assays in an accurate and reproducible manner. Excellent written and oral communication skills. The ability to work well as a team member. Authorized to work in the U.S.