Pharmaceutical Analytical Chemistry Consultant: Method Development-Validation, Drug Stability, cGMP, FDA, and ICH QC

Technical Consultant #2058


Expertise

  • Analytical method development and method validation for small molecule pharmaceuticals.
  • Cleaning validations and cleaning verifications.
  • OOS (Out of Specification) and OOT (Out of Trend) investigations.
  • Stability management.
  • Setting specifications for finished products and API.
  • Project management for CROs (Contract Research Organizations).
  • Formulation development support.
  • Pharmaceutical quality control.
  • Protocol and SOP (Standard Operating Procedures) development.
  • Instrumental and wet chemical analysis.
  • Chromatographic data acquisition systems, data processing, and interpretation.
  • Utilize various CDS (Empower, Chromleon), LIMS, Documentum and MS Office.
  • Technology transfer of analytical methods.
  • Thorough knowledge of USP and other pharmacopeia.

Experience

Undisclosed Company, Sr. Analytical Chemist, 2013 - Present

  • Lead in quality control and research and development activities for a pharmaceutical GMP laboratory.
  • Supervised Q.C. activities.
  • Trained and supervised junior associates.
  • OOS and OOT investigations.
  • Setting specifications for finished products and APIs.
  • Reviewed and wrote protocols and reports for method validations and cleaning verifications.
  • Streamlined and managed stability program.
  • Negotiated service agreement for instruments.
  • Reviewed and revised analytical test methods and SOPs.

Particle Sciences, Inc., Bethlehem, PA, Analytical Chemist, 2010 - 2012

  • Coordinated analytical activities for client projects.
  • Executed analytical development and Q.C. functions for various clients, including testing of raw materials and finished gel, suspensions, and IVRs.
  • Optimized and validated methods for drug eluting devices (antiviral IVRs).
  • Optimized methods for Ibuprofen gel for phase III submission.
  • Managed analytical portion of universal approach of cleaning validation including validation of analytical methods, and collection and processing of equipment cleaning validation samples.
  • Reviewed and wrote protocols and reports for method validations.
  • Presented analytical data to clients.

Sanofi-Aventis, Malvern, PA, Sr. Research Investigator, 1992 - 2009

  • Coordinated analytical support for the development project of Ciltyri tablet, leading to successful NDA filing.
  • Developed and validated assay method to address variability concerns from EMA.
  • Analytical support for API and drug product formulation studies, stability studies, and GMP release of solid oral formulations at early and late stage development.
  • Method development/optimization of comparator products.
  • Method development and validation including protocol development and report.
  • Technology transfer of methods to manufacturing sites.
  • Analytical procedures and reports compatible to CTD, simplifying regulatory submission.
  • Supervised and trained contract staff and student interns.
  • Impact awards for reaching specific milestones for the project.

Research Investigator-Project Support, 1999 - 2005

  • As lead analyst for Ciltyri tablet project, initiated protocols and transferred analytical technologies to manufacturing sites in Europe.
  • Method development and validation including protocol development and report.
  • Drafted a position paper to comply with ERES regulation.
  • Reviewed and revised SOPs.

Principal Research Scientist-Project Support, 1997 - 1999

  • As key analyst successfully completed NDA stability studies for Plavix tablet, a multi-billion drug in the market.
  • Analytical support for API and drug product formulation studies, stability studies, and GMP release.
  • Y2K certification activities for laboratory instruments.
  • Analytical support for toxicological studies.

Sr. Research Scientist-Quality Control, 1992-1997

  • As senior Q.C Scientist, managed and supervised validation and maintenance of purified water system.
  • GMP release testing of API, intermediates and drug product formulations.
  • Cleaning verification testing for manufacturing equipment.
  • Maintained and calibrated laboratory system.

Smithkline Beecham,King of Prussia, PA, Analytical Chemist, 1990 - 1991

  • Analytical support for the biodegradation studies of API.
  • Assay and impurity profile of API.
  • Physico-chemical properties determination of API for environmental assessment.
  • Method development and validation.

Additional Professional Experience

URL Pharma,Philadelphia, PA, Analytical Chemist

  • Release testing for API, intermediates and drug products in Q.C. as per USP, and NF.
  • Developed and validated HPLC methods for assay and degradation products.
  • Prepared validation reports.
  • Trained and mentored junior staff.

Larnett Company, Philadelphia, PA, Analytical Chemist

  • Analysis of drug products and raw materials using USP, NF and other analytical techniques.
  • Preparation of ANDA, SNDA, and package labels and inserts.
  • Follow up communication with FDA.

Solarex Corporation, Rockville, MD, Chemist

  • Process monitoring, process control and trouble shooting in the areas of chemical cleaning, electroplating and photolithography.
  • Improved the chemical cleaning by reducing etching time.
  • Developed a reprocess method for rejected solar cells.
  • Preparation of analysis reports.

Honors & Publications

Languages

  • Gujarati and Hindi (Indian dialects)

Education

  • M.S. Organic Chemistry, South Gujarat University, Surat, India
  • B.S. Chemistry, South Gujarat University, Surat, India
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