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Medicinal Chemist Expert in API Chemical Process Development, Manufacturing Process Start-up and API Process Trouble-Shooting

Technical Consultant #1739


Expertise

  • Synthetic organic chemist and small scale chemical process research and development.
  • Chemical process research and development for "small molecule" drug substances.
  • Guidance for scale-up to provide material for Phases 1 - 3 and manufacturing.
  • Pharmaceutical facility start-up troubleshooting.
  • Assistance with CMC section of filings.
  • Pharmaceutical laboratory process research leading to technology transfer and scale up.
  • Design and implementation of practical, cost-saving, processes and procedures.
  • Experienced with 12 hands-on manufacturing start-ups of drug substances and intermediates.
  • Author of widely-used process chemistry text and experienced instructor of courses on chemical process development.

Experience

Undisclosed Company, Founder, 1997 - Present

  • Company formed for consulting and training with pharmaceutical, biotech, and fine chemicals companies.
  • Providing efficient development of processes to make drug substances and intermediates to pharmaceutical, biotech and CRO/CMO companies.
  • Specific guidance in the preparation of API / CMC regulatory filings, with consideration to process descriptions, specifications, and impurities such as genotoxins.
  • Authored and instructed international courses with over 1200 students and over 150 companies in the area of: Practical Process Research and Scale up.

E. R. Squibb & Sons/Bristol-Myers Squibb, New Brunswick NJ, 1979 - 1997

Principal Scientist, Chemical Technology, 1989 - 1997

  • Developed and monitored manufacturing processes of key intermediates of captopril (Capoten%uFFFF), $1.5 billion peak annual sales), fosinopril sodium (Monopril%uFFFF), aztreonam (Azactam%uFFFF) and other APIs to ensure optimal product quality and profitability.
  • Initiated and introduced simplified process for the manufacture of captopril, resulting in $4 million annual savings by improving productivity and eliminating use and recovery of a solvent.
  • Researched alternative pathways to IND candidates (Mitsunobu reaction, PTC-mediated alkylation) for preparation of clinical supplies.
  • Served as in-house consultant for pharmaceutical process development.
  • Demonstrated in a timely fashion that the processes for the manufacture of aztreonam intermediates could be used to prepare intermediates for drug candidates, thus potentially decreasing development time.
  • Expeditiously developed and scaled up new processes (Fischer indolization, chlorination, %u03B2-lactam formation, oxidation, modified Arbuzov reaction, others) for drug candidates. Helped demonstrate process ruggedness in pilot plant.
  • Served as resource to BMS chemists and engineers, trained hired chemists in process development, including in-house presentations.
  • Assisted BMS Manufacturing, Quality Control, and Technical Registration Resources in identifying impurities, based on process experience.
  • Advised BMS Analytical Research and Development on optimizing derivatizations for GC assays.
  • Assisted with process optimization to remove trace impurities in drug candidates.
  • Authored conception records for alternative processes.
  • Managed interdepartmental task force to determine the source and removal of key trace impurities in bulk captopril.
  • Advised manufacturing colleagues in Puerto Rico on process alterations to successfully optimize manufacturing operations.
  • Generated work on PTC applications and showed that PTC provides a safe effective alternative to the use of NaH / DMF or K2CO3 / DMF for two processes to prepare an API and drug candidate.
  • Redeveloped manufacturing process for the manufacture of a fosinopril sodium intermediate, to ensure all batches exceeded specifications.
  • Successfully introduced process to manufacturing.
  • Responsible for development and successful manufacturing startups of three processes at BMS Ireland facilities.

Group Leader, 1987 - 1989

  • Supervised research activity in Chemical Process Technology by evaluating quality and impact of approaches.
  • Directed 7 chemists (5 Ph.D.s) in the timely development and startup of processes.
  • Chaired Project Team for aztreonam ($155 million annual sales) in an interdisciplinary approach to solving manufacturing problems.
  • Introduced an optimized captopril process (productivity improved by 30%) and processes for new fosinopril sodium intermediates.

Senior Research Investigator, 1984 - 1987

  • Performed process research and development for new products.
  • Responsible for development and successful manufacturing startups of four fosinopril sodium and aztreonam processes at Squibb Ireland facilities. Solved startup problems on the floor.

Research Investigator, 1979 - 1984

  • Performed independent research and development on novel, specialized projects.
  • Developed and introduced key steps for aztreonam: Lactam formation, oxidation of intermediates, and isolation of aztreonam.
  • Simplified manufacturing processes, thus increasing reliability and ultimately profitability.
  • Responsible for development and successful manufacturing startups of five aztreonam processes at Squibb facilities in Ireland and Puerto Rico. Solved startup problems on the floor.
  • Altered process for nadolol (Corgard%uFFFF, $150 million annual sales) to enable optimal profitability.
  • Initiated and developed an aqueous process for nadolol penultimate, which decreased batch time by eliminating a cosolvent.
  • Process was later filed with FDA.

McNEIL Pharmaceutical, Spring House, PA, Chemical Research, 1977 - 1979

Post-Doctoral Fellow

  • Investigated medicinal and process chemistry of pyrrole acetic acids, and other exploratory research.
  • Developed new process for Tolectin%uFFFF intermediate, helping J&J to ward off foreign competition.
  • Developed first chemical preparation of a Zomax%uFFFF metabolite, key for NDA filing.

Honors & Publications


Academic and Professional Affiliations

  • American Chemical Society, Organic Chemistry Division

Awards

  • Received President's Award and Spot Awards in recognition of achievements at E. R. Squibb.

Publications and Patents

  • One book: Practical Process
  • 13 papers.
  • Multiple presentations.
  • 6 U.S. patents.

Education

  • Ph.D. Medicinal Chemistry, University of Michigan
  • B.S. Biology with Chemistry minor, University of Illinois, Champaign, IL
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