Responsibilities
Develop and transfer assays for the GMP release of gene therapy products.
Write development reports, SOP, comparability protocol, justification of spec setting and identify critical quality attributes (CQA).
Collaborate with research group to develop first-in-class drugs.
Lead product characterization activities for gene therapy products.
Troubleshoot problems that occur during product early-stage development, release testing, process development, scale-up or in Manufacturing.
Evaluate product testing results and support product formulation and processes.
Report project status (development plans, timelines) to supervisor and technical teams.
Keep current with all regulatory guidelines, compendia requirements, scientific publications, and technical innovations.
Attend training sessions and conferences in order to maintain and increase skills and knowledge of GXP’s,...