About the Company
For over 5 decades now, we at Bharat Serums and Vaccines Ltd. have used our scientific resources to develop a range of biological, biotech and pharmaceutical products. Advent International, a global PE firm has endorsed its faith in our commitment towards bringing life to life and is partnering with us on an ambitious growth journey.
Job Posting: Principal Scientist
Job Location: Bharat Serums And Vaccines (Bsv), Mumbai · Navi Mumbai, Maharashtra, India (On-site)
Job Type: Full-time · Mid-Senior level
Roles and Responsibilities:
- Process Development of Equine Biologicals & Human Biologicals-Drug Substance & Drug Product-Commercial molecules, Under Development molecules & Third-party manufacturing.
- Scale up of the processes from Lab scale to Manufacturing scale.
- Technology transfer of Equine Biologicals & Human Biologicals Inhouse and Loan license.
- Execution of Engineering Batches, Pre-clinical batches, R & D stability batches, Process Validation batches.
- Alternate vendor development of Critical materials/Consumables-Enzymes, UF DF cassettes, Chromatography Resin, Filters, Virus Filters, RM -PM.
- Should have handled larger team size (At least 5 members)
- Preparation of Project Budget and adhering to Project timelines given to management
Unit operations:
Hands on Experience in handling of Unit operations -Precipitation, Ultrafiltration, Column chromatography, Virus Filtration, Lyophilization.
Documentation:
- Preparation of Documents -MMF, PDR, Chromatography Resin Validation, BMR, SOP, URS, Study protocol, Study report, Risk Assessment.
- Should be able to handle Deviation, Change control, CAPA.
- Preparation of documents for Test license, CMC Documentation, should be able to handle regulatory queries.
- Execution of Non GLP & GLP Virus clearance studies.
- Co-ordination with Cross functional teams.
Additional responsibilities:
- Training of staff and overseeing general lab activities
- Sound knowledge of SEC HPLC, SDS PAGE, Protein content estimation.
Desired Candidate profile:
- 8+ years of relevant experience
- Strong interpretation skills
- Candidate must have experience in Scale up/ Tech transfer.
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