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.