Pharmaceutical Development and Regulatory Expert

Technical Consultant #2259

Development of commercial manufacturing, FDA and international registration and approval for atracurium besylate, trifluoridine, bupropion hydrochloride, zidovudine, exosurf, mivacurium chloride, doxacurium chloride, pseudoephedrine hydrochloride, acrivastine, valciclovir, tramadol hydrochloride, topiramate, levofloxacin, surfaxin, vinorelbine tartrate and lamotrigine.
Major process SNDAs for ofloxacin and leucovorin calcium.
Regulatory documentation and approvals (FDA request for NDAs for grandfathered products) for digoxin, melphalan, azathioprine, thioguanine allopurinol and busulfan.
Chemical pharmaceutical and analytical process development, chemical and pharmaceutical manufacturing:
Contributed to 5 of top 200 Prescription Drugs by U.S. prescription drugs.
GMP compliant and safe processes for pharmaceutical bulk actives (APIs) and finished products.

Undisclosed Company, Director, Global API Formulation Development - Project Management, 1998 - Present

Initiate business opportunities between pharmaceutical clients and world-wide manufacturers with best technology.
Manage projects involving resource allocation, project timelines, technical problems and regulatory compliance between suppliers and clients. Develop new marketing tools.
Identify new technologies and suppliers; research viable technologies for client's needs; identify new clients.
Earned preferred supplier status with one of top international pharmaceutical companies.
First product sales from China. First API from China.
First CMC/IND filed for a Davos customer.
Responsible for both API and dosage form; Project Manager. From tech package to filed IND in 7 months.
Tech transfer of API to commercial manufacturer to support Phase II.
PAI technical liaison for API FDA approvals in Japan and China.
Cytotoxic API and parenteral dosage form from discovery to clinic with regulatory submissions.
Solved analytical and instability issues during compounding. Currently in Phase III.
Antifolate API from discovery to Phase I/II.
Antiviral API redeveloped process and supply chain, Phase II/III
Antiviral AIDS solid oral formulation reproduced originator formulation and then redeveloped for a solid oral dosage form to solve stability problems, Phase II.
Experience with antibody drug conjugates, microbial fermentation, nanoparticles, amorphous solid dispersions, parenterals, dermals and solid oral formulations.

Ash Stevens Inc., Detroit MI, Plant Manager, 1997 - 1998

Responsible for chemical operations and chemical process development: scheduling, plant maintenance, facilities design, process improvement, troubleshooting, process development, business development and project management.
Oversaw staff of Scientists, Technicians and Facilities Staff.
Completed 26 step synthesis of API to deliver 10 kgs.
Implemented plant improvement projects to improve compliance and operability.
Managed Chemical Production for bulk of ASI annual sales.

Johnson & Johnson - Noramco of Delaware, Wilmington DE,Director, Kilo laboratory, 1996 - 1997

Commission and manage a Kilo Laboratory facility for preparation of highly potent active pharmaceutical ingredients.
Responsible for process development and process start-up for 2 APIs in production.
Recommissioned 2 APIs in Production following redevelopment; debottlenecked an API process to double output.
Improved the performance of a critical analytical test; cut sample analysis time by 50%.
Developed containment technology for "shirtsleeves" production of potent APIs (low OELs).

The R.W. Johnson Pharmaceutical Research Institute, Raritan, NJ, 1991 - 1996

Assistant Director, Chemical Development

Direct activities of 2 pilot plants and 2 Kilo Laboratories for 16 scientists (chemists and engineers, Ph.D.s) and departmental office (secretary); prepare clinical trial material and transfer processes to Production (domestic and Europe).
Outside vendor contacts and sourcing for APIs and fine chemicals from Europe and Japan, as well as domestically.
Four NCE NDA's, 1 SNDA approved; 5 Process transfers to Production (3 International, 2 domestic); numerous IND's filed.
Member of various project teams as well as a world-wide team; team leader experience.
Created GMP documentation and SOP's for KL and PP preparation of clinical trial material.
Created a statistical experimental design approach to critical process parameters and used the documentation successfully for 2 PAI's.
Developed solution phase peptide synthesis for 21 AA peptide and produced over 7 kg crude peptide with European affiliate; viable commercial process Prep HPLC process.
Team Leader for project earning J & J Achievement Award for SNDA approval in 45 days.
Expanded Process Safety to include ARC and Dust Explosivity testing.
Systematized the polymorphic characterization of NCEs and critical process parameters.

Burroughs Wellcome Co., Greenville, NC, 1981 - 1991

Director, Chemical & Analytical Development Laboratories

Headed activities of 10 scientists (chemists, Ph.D.s) and Glassware Services; responsible for PP and production technical support.
Eleven NCE NDA's, 4 major SNDA's approved; 6 NCE's commissioned in production; numerous IND's filed.
Established Process Safety Group (RC-1 Calorimeter)- no incidents in either PP or production, even with zidovudine from KL to Production in 6 months.
Established In-process Analytical Group; automated sampling and analysis; valaciclovir scaled from KL to Production in under 12 months.
Production and pilot plant process transfer, troubleshooting and improvement. Cost of zidovudine reduced in half due to yield improvements.

Brookhaven National Laboratories, Upton, NY, 1979 - 1981

USC Comprehensive Cancer Center, Los Angeles, CA , 1976 - 1979

Credentials

Post-Doctoral, Synthetic Organic Chemistry, Brown University, Providence, RI
Executive Program in Business Administration, University of Michigan, Ann Arbor, Mi
Registered Pharmacist, Arizona - R.Ph.
International Society for Pharmaceutical Engineering Wisconsin - R. Ph.

Languages

Raritan Valley Community College, Somerville, NJ,
Bergen Community College, Bergen County, NJ

Academic and Professional Affiliations

Awards

Ph.D. Physical-Organic, Organometallic Chemistry, University of California-San Diego, LaJolla, CA
B.S. Pharmacy, University of Wisconsin, Madison, WI