Pharmaceutical Analytical Chemistry Consultant: Drug Stability, Drug Quality and Regulatory Compliance

Expertise

• Product experience includes brand, generic and drug substance (active pharmaceutical ingredient, API); small molecules, biologics, vaccines; Rx and OTC products; oral, topical, and parenteral dosage forms.
• Pharmaceutical compliance and remediation, quality systems management, data integrity audits, product quality assessments, gap assessments, batch reviews, laboratory and manufacturing oversight.
• Authoring of policies, procedures, training programs. Technical and business writing, editing, and proofreading: Proposals, quality agreements, standard operating procedures (SOPs), protocols, reports, test procedures and regulatory filings. Responses to regulatory inspections.
• Laboratory systems evaluations, best practices recommendations and coaching, analytical chemistry troubleshooting, method development and validation, laboratory investigation training.
• International pharmaceutical stability program management, data review, establishment and justification of specifications, stability chamber selection, setup, qualification and mapping, maintenance and troubleshooting.
• Pharmaceutical analysis: Quality Control (QC) and Research and Development (R&D) of small molecules, biologics / biopharmaceuticals, vaccines; and product development.
• Proficient with all commonly used chemistry laboratory instrumentation and wet chemistry techniques. Analytical instrumentation expertise includes installation, software, troubleshooting, maintenance, repairs and training.
• Chromatography: HPLC, UPLC, Size-exclusion Chromatography (SEC) / Gel Permeation Chromatography (GPC), gas chromatography.

Experience

Independent Consultant, 2009 - Present

• Pharmaceutical compliance and technical auditing, best practices recommendations.
• Technical review and document preparation for regulatory filings.
• Laboratory and stability out-of-specification and out-of trend investigations.
• Batch record reviews and manufacturing auditing.
• Scientific and compliance training / compliance remediation.

International Pharmaceutical/Biologics Brand Company, New Brunswick, NJ, 2004 - 2008

Associate Director, Worldwide Quality and Compliance, Product Stability

• Pharmaceutical stability and analytical chemistry subject matter expert.
• Provided oversight of international stability programs and marketed product testing laboratories.
• Performed product investigations to identify root cause of out-of-specification results and proposed corrective and preventive actions.
• Authored stability reports and health authority responses for international registrations of new drug substances and products and renewals for small molecule and biologic products.
• Represented Technical Operations division on new product project teams and wrote stability protocols and commitments for NDA/BLA filings.
• Wrote stability evaluations for worldwide change proposals. Authored and reviewed corporate directives and SOPs.
• Provided assistance to sites on development of quality systems and SOPs. Reviewed quality agreements and project proposals for third-party development work and stability testing.
• Performed compliance audits as needed.
• Supervised laboratory in absence of laboratory manager.

Lannett Company, Philadelphia, PA, Director of Analytical Services, 2001 - 2004

• Analytical support and leadership for a manufacturer of generic solid dosage forms.
• Managed staff of 50 in Research and Development and Quality Control departments.
• Oversaw method development and validation in support of formulation development, cleaning validation and technical services special projects.
• Managed testing and documentation in support of ANDA submissions, product and process validations, excipient, finished product and stability testing of marketed and research and development products and contract testing.
• Project team leader and member for planning corporate growth and hiring scientists, designing new facility, selecting and developing new products, and evaluating and implementing new initiatives such as improved blend uniformity sampling and testing procedures.
• Hosted audits and managed laboratory, stability and retained controlled substances inventories.
• Primary contact for vendors, clients, FDA, DEA, and other agencies.

Watson Pharmaceuticals, Cherry Hill, NJ, 1997 - 2001

Acting Director of Analytical Services

• Analytical support for firm (formerly Marsam/Schein Pharmaceuticals) specialized in parenteral manufacturing.
• Directed staff of 30 in the Analytical Development, Stability Services and Special Projects groups.
• Oversaw method development, validation and stability testing, controlled substances program in laboratory and stability areas, participated in task forces formed to address FDA observations.

Manager of Stability Services

• Responsible for 15 scientists performing stability testing in support of ANDA filings and marketed products.
• Primary duties included technical direction of the group, data review, statistical analysis, specification setting, authoring justifications of specifications for ANDA submissions, and report writing.
• Responsible for method reviews and transfers, method optimization, equipment qualification and software validation.

Doctoral Studies (during employment with Watson Pharmaceuticals), 1993 - 1996

• Developed HPLC applications and prepared presentations and application notes that showcased separation capabilities of ES Industries HPLC columns.
• Performed laboratory testing, method development and quality audits of data and reports. Founded a company to sell computer equipment, supplies and software.

University of the Sciences in Philadelphia, Pharmaceutics Doctoral Program, 1990 - 1992

• Developed and validated a size-exclusion chromatography (SEC) method for determination of dextran sulfate in serum; enhanced gastrointestinal absorption of the drug in rats.
• Tested, repaired and set up donated laboratory instruments and trained faculty and students on their use.

GlaxoSmithKline, King of Prussia, PA, 1982 - 1989

Pharmaceutical Development

• Performed literature searches and prepared presentations for Vice President of the division.
• Wrote technical documents; reviewed portions of regulatory submissions; provided support for implementation of new departmental systems and procedures.

Head of Stability Testing Group

• Managed the preclinical Research and Development stability team.
• Hired, trained and supervised chemists performing stability testing, method development and validation, API and raw material release testing, and testing of clinical trial stability and complaint samples.
• Participated in technology transfers of analytical methods to quality control group.

Analytical Chemist in Stability Testing Group

• Performed testing of research and development products.
• Maintained and repaired instruments.
• Wrote computer programs to perform calculations.

Organic Chemist in SmithKline Chemicals Division

• Performed organic synthesis of Active Pharmaceutical Ingredients (API) and analytical testing in support of process scale-up.
• Evaluated alternative synthetic routes for APIs.

Honors & Publications

Credentials

• TWIC certified (Transport Workers Identification Credential)
• Thesis title: Dextran Sulfate: Characterization, Determination in Serum, and Enhancement of Gastrointestinal Absorption.

Publications

• 16 presentations / publications, mainly relating to HPLC and SEC.
• Training committee chairperson and instructor, Chromatography Forum HPLC Short Course.

Education

• Ph.D. Pharmaceutics, University of the Sciences, Philadelphia, PA
• B.S. Chemistry, Drexel University, Philadelphia, PA