Sanjaykumar Patel

About Sanjaykumar Patel

Experience of Analytical Research & Development, Quality control and Laboratory operations in pharmaceutical industry. Presently associated with Sigmapharm Laboratories LLC as Group Leader. Coordination of drug substance, excipients and drug product analytical activities at CMOs and Contract Testing Laboratories Experience on writing/reviewing protocol, reports, methods, MDR, SOP, investigations, change control, Laboratory Investigation (like OOS, LE, LIR, NOE), Specifications. Handled deviations and investigations for OOT/OOS Designed strategies and timelines for adequate and accurate responses for IR and CRL letters. Supervised and mentored a group of analytical scientists and working on multiple ANDA\'s and 505(b)(2) projects, and Post Approval Supplements. Conducted various laboratory investigations related to Out-of-specifications, suspected test results and laboratory errors. Handling changes controls through Matercontrol software. Reviewed updates in Pharmacopoeias (USP/EP/BP/JP) and initiated necessary compliance procedures. Developed, directed, and evaluated training programs. Completed analytical instrument qualification, routine instrument calibration, and maintenance on periodic basis. Lead the quality control activities to ensure timely testing and release of all samples (like finished product, API, raw material, packaging material and commercial stability product.) Lead the design and execution of validation projects. Serve as the subject matter expert on specific areas and techniques. Oversee the laboratory for GMP and safety compliance. Performed the analytical method development, method validation, cleaning validation and analytical method transfer. Performed product process validation and instrument qualifications (IQ, OQ and PQ protocols and reports) Knowledge of cGMP, US FDA regulations (21 CFR, part 210,211) and ICH-guidelines. Experience working on writing/reviewing protocol, reports, methods, MDR, SOP, investigations, change control, Laboratory Investigation (like OOS, LE, NOE, Laboratory incident), Specifications.

Experience

1. Manager

   Enzene Biosciences Ltd

   Dec 2024 — Present

Education

• University of Bridgeport

  Master of Science, Technology Management; Biotech and Healthcare Management

  2008 — 2010

• N.V.Patel Pure and Applied Science College

  Bachelor of Science, Chemistry

  2004 — 2007

Skills

• Cleaning Validation
• Gas Chromatography
• Chromatography
• Sop
• Fda
• Computer System Validation
• Hplc
• V&V
• Software Documentation
• Validation
• Standard Operating Procedure (Sop)
• Analytical Chemistry
• Dissolution
• Glp
• Quality Assurance
• Quality Control
• Gmp