Kalpesh Thakkar
Micro SME/leader- Pharma/biopharma/Cell Therapy
- Role
- Qc Principal Scientist- Microbiology at NJ Bio, Inc.
- Location
- Princeton, NJ, US
- LinkedIn followers
- 500 followers
About Kalpesh Thakkar
Quality-focused leader with 16+ years of expertise in the pharmaceutical, biopharmaceutical and cell therapy industries. Recognized as a Subject Matter Expert (SME) in quality assurance, quality control, compliance, aseptic fill operations, contamination control, data review, and technical writing, OOS investigations, deviations, CAPA, change controls, risk analysis, protocols, EM trend reports, and quality metrics. A seasoned leader with over a decade of experience in team management, coaching, performance development, lean leadership, and operational excellence (OPEX), adept at creating high-performing teams and driving organizational success.Skilled in supporting audits and collaborating with cross functional teams for quality inputs for process development. Extensive knowledge in pharmaceuticals, including non-sterile, drug-device combo, medical devices, biopharma, and cell therapy. Highly motivated and committed to achieving quality and project goals effectively while fostering innovation and collaboration across teams.
Experience
Qc Principal Scientist- Microbiology
Jul 2025 — Present · Princeton, NJ, US
Supporting the manufacturing operations for new cleanroom qualifications, utility system performance qualification, sterility assurance/contamination control program- for material, cleaning, gowning, and aseptic behavior evaluations/training, continuous improvement, risk assessments, quality systems (investigations/change controls/deviations) new product launch and microbial analysis.
Education
The University of Texas at Dallas
MS, Biotechnology
2006 — 2008
Gujarat University
B.S, Microbiology
2000 — 2003
Gujarat University
MS, Microbiology
2003 — 2005
Gujarat University
Diploma, Pharmacy
1997 — 1999
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