Tanmaya Nayak
Associate Scientific Manager| Biopharma R&D | mAbs Characterization & Analytical Method Development | BLA Filling to Regulatory filing| Passionate About Biologics Innovation |TrackWise QMS | Veeva QMS l LIMS-ELN
- Role
- Associate Scientific Manager-i, Rnd-as-phys-chem-characterization, Biocon Biologics at Biocon Biologics
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
Experience
Associate Scientific Manager-i, Rnd-as-phys-chem-characterization, Biocon Biologics
May 2023 — Present · Bengaluru, IN
Proficient in method development and method qualification for biosimilar and biologic products. Provided in-process analytical support to manufacturing and development teams. Maintained thorough tracking and management of Reference Listed Drugs (RLDs) for comparability and regulatory compliance. Maintains regulatory compliance with 21 CFR Part 11 and other applicable guidelines. Experienced in using TrackWise for quality event tracking, deviation management, and CAPA documentation. Supports quality systems through structured documentation and process control
Education
KiiT University
Master's degree
2008 — 2010
KiiT University
Doctor of Philosophy - PhD
2014 — 2020
Utkal University
Bachelor's degree
2005 — 2008
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