Validation Consultant and Process Development of Clinical Drugs (714)
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