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

Technical Consultant #2058

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.

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

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.

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