Expertise

• Identify, evaluate & recommend contract manufacturers for clinical & commercial scale drug substance (API) & dosage forms for topical, solution, solid dosage, and injectable projects.
• Manage ongoing outsourced manufacturing activities for API and drug product for 4 virtual pharmaceutical companies.
• Draft & negotiate supply and quality agreements with GMP contract manufacturers.
• Review and edit CMC sections of IND Annual Report filings for a new peptide drug product. Provide technical, regulatory and QA guidance to the virtual company developing this product.
• Prepare detailed Scope of Work document for a process development project being outsourced by a major generics company.
• Represent pharmaceutical clients at project meetings, FDA meetings, and on-site during manufacturing campaigns. Prepare FDA briefing documents for pre-IND and EP2 meetings.
• Review and edit development report, batch records, and technology transfer protocols for sterile pharmaceutical product.
• Prepare and review validation master plan and process validation protocols for commercial scale active pharmaceutical ingredient synthesis.
• Audit contract manufacturing facilities to assess cGMP compliance.
• Project planning for a new biotech company's first IND filing.
• Write, review, and/or revise SOPs, analytical methods, and project specifications for raw materials, drug substance, and drug product, and to establish a quality assurance system.
• Draft and edit CMC sections for IND and NDA filings and assist contract manufacturer in DMF preparation.
• Perform due diligence investigations for potential product and technology acquisitions by client biotech companies, including peptide and protein products and medical devices.
• Developed strategic plan for in-house and outsourced development activities directed toward IND filing & clinical studies on two new chemical entity therapeutics.
• Cost analysis assessment of commercial viability of potential drug substances.
• Staffed & equipped in-house analytical development and peptide synthesis groups.
• Identified & evaluated outside supplier for scale-up & production of bulk peptides under cGMP, formulation development, and clinical dosage form manufacturing.

Experience

CDR Therapeutics, Seattle Washington, Director, Chemical Dev.; Acting Director, Medicinal Chemistry

Responsible for establishing the chemical development and drug discovery functions at a new biopharmaceutical company, with the goal of developing peptide and/or small molecules as therapeutics based on the CDR regions of antibodies.

• Developed strategic plan for a combination of in-house and outsourced development activities directed toward IND filing & clinical studies on two new chemical entity therapeutics
• Cost analysis assessment of commercial viability of potential drug substances
• Staffed and equipped in-house analytical development and peptide synthesis group
• Identified & evaluated outside suppliers for scale-up & production of bulk peptides under cGMP
• Formulation development, and clinical dosage form manufacturing
• Designed and cost-effectively equipped a chemistry laboratory for a new facility
• Developed HPLC methods for evaluation of purity & stability of 4 lead compounds and for identification of major degradation products

ProCyte Corporation, Kirkland, WA, Director, Chemical Development; Manger, Process Development

Responsible for leadership of chemical development group in process development, analytical methods department, clinical manufacturing for drug substances, formulated drug products & medical devices, and validation activities

• Development & transfer to manufacturing of a process for synthesis of a tripeptide copper complex as a BPC and device component. Reduced cost of goods by >95% from the cost of purchased material by utilization of an unconventional synthetic route & less costly starting materials
• Development, scale up, clinical & commercial production of derivatized polymers as wound care device components - 7 months from acquisition of core technology to production of first commercial materials, utilizing a staff initially unfamiliar with polymer chemistry
• Led project team responsible for initiating commercial manufacturing of OsmoCyte R line of polymer-based wound care devices, including raw material sourcing, process, specification & method development, primary manufacturing equipment design, packaging, cost analysis and production planning
• Led troubleshooting teams for investigation of raw material or product failures, and for providing continued cost reductions through process improvements

Berlex Laboratories, Cedar Knolls, NJ, Scientist, Biophysical Chemistry; Scientist, Peptide Chemistry

• Solid phase and multi-gram solution syntheses of peptides and cyclic peptide analogues as potential enzyme inhibitors and receptor antagonists
• Combined techniques of solid phase and solution chemistry to synthesize defined-size oligomers of polycationic lipid-lowering agents for calibration of size-exclusion HPLC method

Immunobiology Research Institute, Senior Research Scientist, Peptide Development

Ortho Pharmaceutical, Senior Research Scientist, Peptide Development , Research Scientist, Peptide Development

McNeil Pharmaceutical, Postdoctoral Fellow, Medicinal Chemistry

Honors & Publications

PROFESSIONAL ASSOCIATIONS

• American Chemical Society
• American Peptide Society
• International Society of Pharmaceutical Engineers - Invited Speaker
• International Association of Pharmaceutical Science & Technology
• Drug Information Association
• Washington State Biotechnology Association
• Telementoring Young Women in Science

PUBLICATIONS

• Seven in leading scientific journals

Education

EDUCATION

• Ph.D., Organic Chemistry, Michigan State University
• B. S., Chemistry, Michigan State University

CONTINUING EDUCATION

• GMP Manufacturer of Bulk Drug Substance
• Bulk Active Pharmaceuticals - A Current Regulatory Perspective
• Outsourcing Pharmaceutical Manufacturing
• Process Validation
• Design & Validation of Pharmaceutical Facilities
• Compliance Auditing for Pharmaceutical Manufacturing
• HPLC Methods Development
• Practical Hydrogenation Technology
• Quality & GMP Auditing
• Lyophilization, Freeze Drying Technology
• Financial Accounting for Non-financial Managers
• Management Techniques for Scientists
• American Peptide Symposium