Navdeep Grover
Staff Scientist at Regeneron Pharmaceuticals, Inc.
- Role
- Staff Scientist at Regeneron
- Location
- Rensselaer, NY, US
- LinkedIn followers
- 500 followers
About Navdeep Grover
Analytical development and Quality Control leader with 9+ years of experience advancing monoclonal antibodies, bispecifics, recombinant proteins and AAVs through late-stage development. Expertise in defining analytical control strategy, leading ICH-compliant method validation, lifecycle management, compendia verification (USP/EP/JP), comparability assessments, and global method transfers supporting IND and BLA filings.9 years of post-doctoral research experience in molecular biology, protein engineering, purification, assay development, and formulation development. Co-inventor on one patent and author of 15 peer-reviewed publications and 3 book chapters.
Experience
Staff Scientist
Dec 2024 — Present · Rensselaer, NY, US
Technical Leadership: Designed analytical strategy for assay development, optimization, qualification, and validation as per ICH guidelines for mAbs (traditional and bispecific) and AAVs.Designed comparability studies for change in analytical test methods.Led technical troubleshooting and problem investigations (EOEs, GLIFs, LTIFs, CAPA, and Change controls).Authored SOPs, analytical development reports, assay validation protocols & reports, transfer protocols & reports, investigation test plans, and methods life cycle reports (assay performance).Supported release testing, stability testing, and reference standard testing.• Project Leadership: Led analytical assay transfer to business partners and CMOs.Liaised across multiple departments (CMC, QA, Statisticians and QC labs) to support assay development, validations, and comparability studies.Provided SME support for analytical sections of BLA filings (3.2.S.4.2 and 3.2.S.4.3), FDA audits, and information requests (IRs) from regulatory agencies.• Professional Leadership:Led a team of Scientist and Sr ScientistSupervised, trained, and mentored analysts and juniors in the group.
Education
Indian Institute of Technology Delhi
MSc, chemistry
2003 — 2005
Kirori Mal College, University of Delhi
Bachelor of Science, Chemistry
2000 — 2003
Indian Institute of Technology, Delhi
Doctor of Philosophy (Ph.D.), Bioengineering and Biomedical Engineering
2005 — 2010
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