Assistant Manager-Bio-Analtical Development

Job Description: Bio- Analytical Development, Vaccine R&D Experience in leading a team for analytical method development, Validation and Characterization for Vaccines and Biologicals Handling of Bio-Analytical Instruments like Gel- Electrophoresis, PCR, Real-time PCR, Gel Doc, ELISA reader, Multimode reader, Flow cytometer, Microscope, Fluorescent Microscope etc. Handling of various cell lines used for Bioassays. Hands on experience in Biochemical and Immunological methods development and validation for Recombinant and Non recombinant Bacterial and Viral Vaccines. Execution of immunochemical assays eg. ELISA, Rocket electrophoresis, ELISPOT etc. and cell based assays. Strong knowledge on in-vitro and in-vivo potency studies. Experience of CMC, RCGM dossier preparation Thorough understanding of ICH, WHO TRS, FDA, EMA guidelines Preparation of in-process, Drug Substance and Drug Product specifications and COA for Recombinant and Non recombinant Bacterial and Viral Vaccines. Preparation and review of stability study protocols as per ICH guidelines Ensure Good Laboratory Practices in ADL laboratory. Annual budgeting, tracking of expenditure and ensure timely procurement planning for availability of raw materials, Kits and consumables. To maintain equipment log books and Lab note Books for the executed experiments. Communication with Various vendors regarding chemical reagents and Instruments. Must be familiar with cGXP documentation, new method development and product specifications etc. Analytical method transfer to QC with Summary report. To plan the activities with maximum output with documentation and compliance. Any other specific work for assignment given by the section head/department head.

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