Summary
Overview
Work History
Education
Skills
Websites
Knowledge Of Computer And Analytical Acquisition Softwares - Softwares
References
Languages
Timeline
Generic

Sanjaykumar Patel

Dayton,USA

Summary

  • A dynamic professional with 13 years of rich 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,excipient 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.

Overview

13
13
years of professional experience

Work History

Group Leader

Sigmapharm Laboratories, LLC.
06.2018 - Current
  • Mange and performed analytical tasks as assigned for Development and Validation for Analytical Methods (like Assay, Impurities and Residual Solvent, Particle Size, XRD) and other laboratory testing.
  • Provide comprehensive formal and informal leadership to promote work environment and communicate overall business expectation to QC.
  • Supervise scientist and chemists to include, but not limited to overseeing testing, check progress of samples for release and ensure assigned tasks are performed on timely manner.
  • Work distribution among scientist & chemists based on priorities.
  • Ensures communication flow in team and support to peers and managers.
  • Recommended and executed quality improvements for production and product quality.
  • Author, Review and approval of Validation Protocols, Validation Reports, Methods and Standard Test Procedures.
  • Interaction with Co-Departments Such as Formulation R&D, Regulatory Affairs, Quality Assurance and Manufacturing, to support timely new product development.
  • Mange Laboratory Investigation of Out of Specification results (OOS), Out of Trend (OOT) Analysis and Laboratory Deviations.
  • Support ANDA/NDA projects from development to approval with guidance.
  • Experience of writing, reviewing and updating Validation Protocols/Reports, Test Procedures.
  • Reviewing STM, SOPs, Stability testing data and auditing laboratory note books and instrument calibration records.
  • Experience of creating, updating, revising of Standard Operating Procedures.
  • Coordinate quality management review technical document and testing procedure.
  • Experience in processing and reporting of analytical data using EMPOWER III.
  • Support investigation and troubleshooting of analytical issues.
  • Experience of working with various analytical instruments like UPLC, HPLC, GC, Particle Size, XRD, UV, FTIR, KF, Atomic Absorption Spectrometer, TOC, Dissolution Apparatus I, II, III, Auto titrator, Polari meter.
  • Working knowledge of regulatory requirements including cGMP, cGLP.
  • Monitoring reagents, in-house and USP standards, GC standard and laboratory supplies.
  • Maintaining an orderly laboratory environment.
  • Train new employees on basic laboratory techniques and maintain their training records.
  • Assist in maintaining the laboratory in compliance with SOPs, cGMPs, FDA and OSHA.
  • Compiling and storing of all laboratory records.
  • Developing Stability Summery Reports and Stability Trending Report.
  • Manage metrology department including calibration of instruments, vendor scheduling for PM and instrument repair (like UPLC, HPLC, GC, Particle Size, XRD, AAS, UV, TOC, Polari meter, FTIR, Dissolution Apparatus I, II and III, Auto Titrator).

Senior Analytical Scientist-III

Sigmapharm Laboratories, LLC.
01.2017 - 05.2018

Senior Analytical Scientist-I

Sigmapharm Laboratories, LLC.
06.2014 - 12.2016

Analytical Scientist

Sigmapharm Laboratories, LLC.
12.2013 - 05.2014

Analytical Chemist

CisPharma Inc.
12.2010 - 11.2013
  • Perform physical and chemical testing of raw material, packaging material, in-process, finished product and stability samples
  • Record experimental data, analyze results, and maintain accurate and up-to-date notebooks
  • Review R&D notebooks and raw data for cGMP compliance
  • Support method development and method validation work
  • Assist in maintaining the laboratory in compliance with SOPs, cGMPs, FDA and OSHA
  • Use and maintain instruments like HPLC, GC, Dissolution, UV-VIS, IR, Titrator etc
  • Troubleshoot and perform minor maintenance and repair of lab instrumentation
  • Write technical documents (for example specification, test methods, protocols and reports)
  • Periodically review SOPs for compliance with cGMP and revise SOPs, if necessary
  • Execute EQ protocols and set up Qualification program for new instruments with some guidance
  • Perform calibration and maintenance of various analytical equipment
  • Maintain control of all samples submitted to the laboratory
  • Provide formal/informal mentoring to Technicians
  • Perform other duties assigned by supervisor
  • Experience in processing and reporting of analytical data using EMPOWER II.

Education

Master of Science - Technology Management

University of Bridgeport
Bridgeport, CT
05.2010

Bachelor of Science - Chemistry

N.V. Patel Pure And Applied Science College
Gujarat, India
04.2007

Skills

  • Task prioritization
  • Coaching and mentoring
  • Relationship Building
  • Active listening
  • Goal setting
  • Adaptability
  • Continuous improvement
  • Problem solving
  • Technical expertise
  • Project management
  • Time management
  • Analytical thinking
  • Organizational skills

Knowledge Of Computer And Analytical Acquisition Softwares - Softwares

  • Master control
  • Novatek stability software
  • Microsoft Office (MS Word, Power point and Excel)
  • Waters Empower2 & 3 software

References

References will be provided upon request.

Languages

English
Full Professional
Gujarati
Full Professional
Hindi
Full Professional

Timeline

Group Leader

Sigmapharm Laboratories, LLC.
06.2018 - Current

Senior Analytical Scientist-III

Sigmapharm Laboratories, LLC.
01.2017 - 05.2018

Senior Analytical Scientist-I

Sigmapharm Laboratories, LLC.
06.2014 - 12.2016

Analytical Scientist

Sigmapharm Laboratories, LLC.
12.2013 - 05.2014

Analytical Chemist

CisPharma Inc.
12.2010 - 11.2013

Master of Science - Technology Management

University of Bridgeport

Bachelor of Science - Chemistry

N.V. Patel Pure And Applied Science College

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