Manojkumar V
Senior Team lead; Global Extractables & Leachable and Impurity ID, Nitrosamines & Elemental impurities
- Role
- Senior Team Lead at 화이자
- Location
- Chennai, TN, IN
- LinkedIn followers
- 500 followers
About Manojkumar V
Extractable Leachables and Analytical Team Leader with 15 years of Pharmaceutical and Medical Device experience and research experience. • Currently leads a team of mid to senior level scientists focusing on Extractables and Leachables, Analytical Method Development and Validation, and Mass Spectrometry Analysis for Parenteral Products. • Well versed with PQRI, USP, USP, USP and USP and good understanding on Device E&L guidelines ISO-10993 Part-1, Part-12, and Part-18. • Mentors and encourages team to innovate and maintains a strong operational framework. • Demonstrated annual cost savings to the project and organizational budget through continuous improvement initiatives. • Good exposure in setting up an E&L Lab with mass spectrometry instruments including qualification of new instruments. • Established a simplified workflow for identification of unknowns by LC-HRMS. • Participated in FDA meetings to provide response to deficiencies.
Experience
Senior Team Lead
Sep 2022 — Present · Chennai, IN
Education
National Chemical laboratory
Doctor of Philosophy (Ph.D.), Oraganic chemistry
Pondicherry Central University
Master's degree, Chemical science
2006 — 2008
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