Analytical Chemistry, Drug Stability and Out of Specification Investigation

Technical Consultant #1790


Expertise

Summary

  • Pharmaceutical quality and compliance, analytical method development and validation.
  • Interpretation of changing regulations.
  • Thirteen years of pharmaceutical industry experience operating within both GLP (Good Laboratory Practices) and GMP (Good Manufacturing Practices) environments that included eight years of pharmaceutical research and development, hands on technical and research experience, in analytical method development, validation, and application and five years of technical and administrative experience in global marketed product quality and cGMP (Current Good Manufacturing Practices) compliance.
  • Writing and reviewing regulatory, scientific, and technical documents, including stability content of initial global marketing applications, (section 3.2.P.8 - drug Product Stability and section 3.2.S.7.2 - drug substance post approval stability protocol and stability commitment).

Pharmaceutical Quality and Compliance

  • Deviations, OOS (Out of Specifications) and OOT (Out of Trend) investigation.
  • Manufacturing change control assessment.
  • Batch record review.
  • Application integrity review - data integrity, methods integrity, change filing and implementation integrity.
  • Review of annual product reports.
  • Executive summary reports.

Analytical Method Development and Validation

  • Chromatography.
  • HPLC (High Performance Liquid Chromatography) MS-MS (Mass Spectrum).
  • Sample preparation - Liquid-liquid extraction, solid phase extraction, protein precipitation.
  • Automation.

Drug Development and Dossier Support

  • Non-clinical and clinical studies analytical support.
  • Stability support for new filing and application renewals.

Technical Experience and Skills

  • Robotic automation of high throughput sample processing in 96-well format.
  • Aqueous and non-aqueous electrochemistry and electrode processes.
  • Synthesis and characterization of coordination complexes of transition metals with thioethers and amino acids.

Experience

Independent Pharmaceutical Consultant, Product Quality Assessments, 2010 - Present

Contributions

  • Reviewed manufacturing and critical parameters change filing and implementation for application Integrity.
  • Reviewed batch records for multiple products.
  • Reviewed stability data Integrity of submission batches for multiple products.
  • Reviewed analytical method integrity of submission batches for multiple products.
  • Reviewed laboratory investigation documentation to assure that the product performance assessment criteria were met.
  • Reviewed annual product reports for multiple products.
  • Prepared executive summary reports for multiple products.
  • Oversaw QC laboratories at the restart of manufacturing operation.

Schering Plough/Merck, Summit, NJ, Global Quality and Stability Consultant, 2009 - 2010

  • Optimization and integration of Latin American marketed products manufacturing operation.
  • Led a team of stability experts in an ongoing project for identification and remediation of quality and stability gaps in Latin American marketed products manufacturing operation for more than 100 solid, semisolid and liquid dosage forms including parenteral, oral, topical and nasal products.
  • Led teams at the manufacturing sites in the preparation of dossiers to support the Latin American manufacturing consolidation and product transfers.

Bristol-Myers Squibb (BMS), New Brunswick, NJ, Associate Director, 2004 - 2008

  • Provide oversight of worldwide stability operation and marketed product testing.
  • Investigate out of specification (OOS) results and determine necessary corrective and preventive actions (CAPA) using TrackWise system.
  • Provide guidance to third party manufacturing on drug stability matters.
  • Conduct internal audits, provide support to sites during FDA audits and represent stability during FDA audits.
  • Author and review the "stability" sections of the "quality" module of drug product for NDA (New Drug Applications) and ROW (Rest of the World) filing.
  • Supervised sixteen employees and managed marketed product stability testing and administration.
  • Oversaw global quality operation and directly investigated quality issues at the EMEA and Asia/Pacific manufacturing sites and provided guidance to the sites in handling deviations.
  • Successfully led Fact Finding meetings, drafted field alerts for submission to the FDA and participated in Product Review Committee meetings to recommend appropriate market actions.
  • Trained personnel from all global sites (EMEA, Asia/Pacific and the Americas) on investigating and documenting OOS/OOT results.
  • Authored directives and SOPs (Standard Operating Procedures) for global marketed products stability program.
  • Member of team responsible for writing NDAs, including one of BMS's first QbD (Quality by Design) filings.
  • Authored and reviewed stability protocols and reports for inclusion in new marketing applications and renewals.
  • Assessed and approved manufacturing and testing standards change controls from the quality GMP perspective.
  • In collaboration with the quality statistics group, performed stability assessment for specifications and expiry periods of BMS products under zone IV storage conditions.

Senior Research Investigator, 2000 - 2004

Research Investigator, 1996 - 2000

  • Develop, validate, implement and apply methods for the analysis of pharmaceutical compounds in biological matrices and metabolic profiling of drug candidates.
  • Author and review the bioanalytical portion of the pharmacology section of IND submissions.

Contributions

  • Developed and validated robust robotic sample extraction procedures and automated high throughput LC (Liquid Chromatography) and MS/MS methods to reduce the turnaround time of sample analysis for preclinical and clinical studies.
  • Received several spot awards and President's award for accomplishing analysis of more than 500 samples routinely in a single unattended run.
  • Developed generic platform for the automated screening of biological sample extraction procedures using Packard robotic system to minimize matrix effect.
  • Designed and contracted out pearceable caps for direct robotic sampling of biofluids from sample tubes to improve efficiency, sample integrity and analyst's safety.
  • Designed and contracted out sample tubes with identical external dimensions as standard sample tubes for direct sampling of small volumes collectable from small animals like mice.
  • Investigated the complex mechanism of acyl migration in an acyl glucoronide.
  • Investigated and developed method for one-pot derivatization and extraction of thiol compounds in biological fluids.
  • Investigated and developed method for one-pot reduction, derivatization and extraction of disulfide for total thiol analysis in biological fluids.
  • Successfully convinced the upper management that the existing sample analysis operation was inefficient and subsequently harmonized the HPLC instrumentation across department to streamline the analytical operation with improved efficiency.

Indiana University, Indianapolis, IN, Research Associate, 1993 - 1996

  • Develop and validate HPLC-MS/MS and extraction methods for the analysis of anabolic steroids.
  • Successfully synthesized for the first time and structurally characterized deuterium-labeled epitestosterone glucuronide for quantitative determination of testosterone/ epitestosterone (T/E) ratio in urine samples to investigate doping of anabolic steroids.
  • Optimized conditions for selective solid phase extraction of steroid conjugates (glucoronides and sulfates) from urine.

Honors & Publications

Academic and Professional Affiliations

  • American Association of Pharmaceutical Scientists (AAPS)
  • Pharmaceutical Research and Manufacturers of America (PhRMA)

Awards

  • PRI Star Award: Pharmaceutical Research Institute (PRI), Bristol-Myers Squibb
  • Numerous Spot Awards for significant achievements at Bristol-Myers Squibb.
  • President's Award: Bristol-Myers Squibb
  • Excellence Award: Bristol-Myers Squibb
  • The Phillips/McCollum Research Fellowship: The University of Kansas

Publications and Patents

  • Author and Co-Author of 14 publications and numerous presentations.

Education

  • Ph.D. Analytical Chemistry, University of Kansas, Lawrence, KS
  • M.B.A. Pharmaceutical and Marketing Management, Rutgers University, Newark, NJ
  • M.S. Bioscience Regulatory Affairs, Johns Hopkins University, Baltimore, MD
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