Responsible for release of the product by ensuring review of relevant audit trial of Manufacturing. Strong knowledge of cGMP, ICH guidelines, FDA regulations, and other relevant standards for biologics manufacturing.
Should have hands on experience in Water samples analysis, In-process Bioburden and BET analysis, MLT analysis of Raw material and packing material, Antibiotic assay by Microbial method.
M.Sc 1st Division or Ph.D in Chemistry/Bio-Chemistry /Toxicology/Forensic Science with Forensic Chemistry and Toxicology subjects or its equivalent qualification in any one of the above subjects/disciplines
Postgraduate degree in Life Science / Biotechnology / Botany / Biochemistry. Scholars who are selected through National Eligibility Tests-CSIR-UGC-NET, including Lectureship, GATE and GPAT
B.Tech, M.Tech, M.Sc.in Life Sciences OR Biotechnology OR related, associated fields, with knowledge of Mammalian cell culture, immunology techniques, immune cell handling, cell staining, FACS, protein purification techniques, ELISA.