Kalpesh Thakkar
Qc Principal Scientist- Microbiology @NJ Bio, Inc.
Signup · Get unlimited contacts
WORK HISTORY
Qc Principal Scientist- Microbiology @NJ Bio, Inc.
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
Gujarat University
B.S, Microbiology
Gujarat University
MS, Microbiology
Gujarat University
Diploma, Pharmacy
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.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.