Seeking a mid-senior or senior management role
in an Analytical R&D or QC of a well reputed pharmaceutical
company where I can utilize my strong leadership, managerial and
technical skills to make a significant contribution to
company's success and growth.
Extensive pharmaceutical fast pace analytical chemistry/ research and development experience with strong leadership, managerial, technical and team building skills. In-depth knowledge of CMC/ FDA, ICH, QA/ QC, DEA and regulatory compliance. Built and led cross functional teams through active teamwork to meet objectives and to obtain maximum productivity with aggressive time lines. Demonstrated management and interpersonal skills to lead a vibrant and productive analytical department, bringing high quality/compliance standards in the department.
Lab Startup & Management
FDA, ICH, DEA
Team building and Training
CMC, ANDAs, NDAs
Director, Analytical R&D, 02/2011 to 02/2013 SANDOZ, INC – East Hanover, NJ
Led and managed five teams with 42 team members and filed high quality ANDAs on solid/solution/suspension dosage forms, and also provided support for the department from groups, namely, metrology, centralized reference standard system, stability program, method transfers and compliance audit.
Built high quality standards in AR&D through new/ revised SOPs and training in the department.
Ensured that all lab operations meet all compliance and regulatory guidelines.
Developed and validated test methods to release drug substance, drug product and intermediates.
Established regulatory specifications for drug substances, drug products and successfully filed numerous filings with the FDA.
Achieved successful corporate internal audit, the FDA PAIs and site GMP audit with no observations.
Reduced lab supply cost by about 40% by channelizing all the purchase orders through one supplier, and also giving a cost saving target for supplier to meet.
Developed paperless system and auto calculation.
Director, Analytical R&D, 07/2003 to 02/2011 TEVA PHARMACEUTICALS (FORMERLY BARR LABORATORIES) – Pomona, NY
Led and managed four teams with 33 team members and filed high quality ANDAs of solid/solution/suspension dosage forms and also provided support for the department from groups, namely, metrology, centralized reference standard system, lab-supply, method transfer and compliance audit.
Instrumental in developing highly efficient and productive teams through proper coaching and mentoring the team members and through close follow up on results.
Instrumental in improving quality standards on instrument qualifications through introduction of additional parameters evaluation requirement.
Achieved successful corporate internal audit and also the FDA's general GMP audit for site.
Developed and validated test methods to release drug substances, drug products and intermediates.
Established regulatory specifications for APIs, drug products and successfully filed numerous ANDAs.
Led and managed two teams with 18 team members and filed high quality ANDAs of different dosage forms.
Associate Director, Analytical R&D, 07/2001 to 07/2003 BARR LABORATORIES, INC – Pomona, NY
Led and managed two teams with 18 team
members and filed high quality ANDAs of different dosage forms.
Developed and validated test methods for drug substances and drug products.
Built, organized and trained project teams.
Successfully filed several first to file ANDAs through quick turnaround time on lab activities.
Successfully performed speedy technical transfers to QC (two products per month).
Senior Manager; Manager; Technical Group Leader, BARR LABORATORIES, INC – Pomona, NY
solution, suspension, etc.
Developed and validated test methods in compliance with ICH/ FDA guidelines.
Established regulatory specifications for APIs and drug products prior to filing ANDAs.
Successfully performed technology transfer of all new analytical test methods to QC.
Team Coordinator; Staff Analyst, BARR LABORATORIES, INC – Pomona, NY
Research Scientist, AMERICAN CYANAMID LEDERLE LABORATORIES, INC – Pearl River, NY
Microbial Chemistry Research - Discovery products.
MASTER OF SCIENCE (MS): PHARMACEUTICS/ INDUSTRIAL PHARMACY, Long Island University - Brooklyn, NY
MASTER OF SCIENCE (MS): BIOCHEMISTRY, University of Bombay - Mumbai, Maharashtra, India
BACHELOR OF SCIENCE (BS): CHEMISTRY, University of Bombay - Mumbai, Maharashtra, India
DIPLOMA: BUSINESS MANAGEMENT, Indian Merchants' Chamber - Mumbai, Maharashtra, India
Chemical Society (ACS)
American Association of Pharmaceutical
Validation of an Enzymatic Method for the Determination of Trace
Levels of Ethanol.
Drug Development and Industrial Pharmacy, 25(8), 929-935 (1999) R.
V. Alvencar, S. Lam, M. Siddhom, and T. U. Okater.