About Navin
Hindi
Native or bilingual
Experience
- ConsultantProduct Quality AssociateApril 2022 - Today (4 years and 2 months)
- Stelis BiopharmaTeam LeaderOctober 2019 - April 2022 (2 years and 6 months)Bengaluru, Karnataka, India
- Zydus BiologicsDeputy Manager - Quality AssuranceApril 2016 - October 2019 (3 years and 6 months)Ahmedabad, Gujarat, India• Involved in commercial production of therapeutic recombinant proteins of microbial origin (GCSF, PEG-GCSF, IFN, Teriparatide) and mammalian origin (EPO, Trastuzumab, Adalimumab, Bevacizumab, Rituximab, etc)• To approve Certificate of Analysis (COA) for batch release and stability samples.• Handling of OOS, OOT, laboratory incidents, change control, deviation.• Responsible for stability and retention sample management.• To review and approve the method validation/transfer related documents.• To review the manufacturing process to reduce sampling.• LIMS implementation to achieve "Paperless QC".• To participate in Management review meetings and development activities.
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Education
- Doctor of Philosophy (PhD), BiotechnologyBirla Institute of Technology and Science2014Doctor of Philosophy (PhD), Biotechnology
- M.Sc., BiotechnologyRajiv Gandhi Biotechnology Centre, Nagpur2008M.Sc., Biotechnology
Skill set (4)
Categories
- Other