PhD in Biology, Biochemistry, Biotechnology or related Life Sciences discipline, plus 10 years of experience in any suitable occupation in the pharmaceutical andor biotechnology industry with 5 years leadership and team management experience in biologics process development within viral vectors and gene therapy. Experience must include 10 years of drug product and process development FermentationCell Culture, Purification, and Formulation, manufacture of clinical supplies, development of efficient and scalable manufacturing processes to support regulatory filing CMC INDs, IMPDs, BLAs. Technical scientific experience in viral based production, in particular viral based production on avian cell line primary and continuous cell lines. Experience in process development of viral based vaccines and therapeutics working with CDMO environment. Experience working with government agencies. Must have worked in cGMP environment following relevant regulatory guidelines i.e. ICH, FDA, and EMA.
Categories: eb3
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