Pharmaceutical and Biotechnology Manufacturing Enterprise Consultant

Expertise

• Chemistry consulting for the pharmaceutical and biotechnology industry from gram scale proof of concept to multi-ton manufacturing synthesis for savings of millions USD dollars.
• Process chemistry synthesis route selection, development and optimization for preclinical drug substances.
• Converting batch processing to continuous processing and green chemistry execution for manufacturing syntheses.
• Chemistry, Manufacturing and Control (CMC) leadership for regulatory submission of IND, NDA, IMPD and MAA quality section applications.
• Organometallic, organotransition and precious metal chemistry consulting for mining, refining and recycling industry.
• Food Chemistry ingredients investigation and interaction based on carbohydrates, amino acids, and additives for flavor enrichment.
• Legal deposition and consulting as an expert witness for defending clients' intellectual property.
• Pharmaceutical Due Diligence. Consulting for selection of CDMO (Contract Development Manufacturing Organizations) ensuring compatibility among working companies.
• Synthesis interface with engineering, ananlytical chemistry and manufacturing.
• Due diligence for partnering or acquisition of pharmaceutical products.
• Scientific collaborations with academic, government and professional societies.

Experience

EXPERT WITNESS EXPERIENCE

• Expert witness for process chemistry manufacturing. Successful defense on the manufacturing synthesis of the drug substance with detailed explanation of the chemistry technical data in US federal court and EU Patent Agency.
• Patent Defense. 3 Companies

PROFESSIONAL EXPERIENCE

Unidentifiable Company, 2021 - Present

President (Independent Consulting)

Leveraging practical industrial chemistry knowledge and experiences to the chemistry enterprise. Clients include phaarmaceutical companies, biopharma startup, the food industry and rare earth metal manufacturing company.

Voisin Consulting Life Sciences (VCLS), 2018-2021

Associate Director, Chemistry Manufacturing and Control (2 Years)

CMC regulatory preparation of IND, IMPD, NDA, MAA. Prepared the 3.2 sections of the electronic common technical documentation (eCTD) for global regulatory submissions. Served as CMC consultant to clients' pharmaceutical projects during regulatory global submissions from clinical development to dommercial approval phases.

Eli Lilly and Company, Indianapolis, IN,1989 - 2017

Research Advisor, Pharmaceutical Process Design and Development (28 Years), Small Molecules Design and Development Research Advisor (2004-2017 retired), Senior Research Chemist (1998-2004), Research Scientist (1994-1998), Senior Organic Chemist (1989-1994)

Pharmaceutical process research and development for the drug substance and drug product: a) design and development of synthesis methodologies from lead (milligram) to commercial manufacturing (metric ton), b) lead cross-functional teams for process development of clinical trials drug substances and drug product support, c) provide CM&C regulatory leadershop from pre-IND, IND and NDA along with global regulatory (FDA, CMA) interactions, d) partner with CMO (contract manufacturing organizations) networks for drug substance delivery.

Emory University, Atlanta, GA. Fall 1984 - Fall 1988, Department of Chemistry. Graduate Student. Synthesis of bilogically active compounds using novel organometallic and organic methodology.

Procter and Gamble Company, Cincinnati, OH, 1984, Summer Intern. Assisted in the improvement of the potato chip flavor oa a particluar salted snack.

Burroughs Wellcome Company, Research Triangle Park, NC 1983, Summer Intern. Designed new method in the multigram systhesis of a drug to be used in early phose clinical trials.

Hess Oil Company, St. Croix, US Virgin Islands, 1980- 1982, CoOp & Summer Intern

Applied basic qualiytative tests used in an oil refinery.

Honors & Publications

AWARDS

• Eli Lilly President's Awaard (Highest Scientific Award at Eli Lilly)
• Fellow of the American Chemical Society

PUBLICATIONS & PATENTS

• Over 11 publications between 2017 and 2020
• Over 5 patents between 1992 and 2006

Education

Ph.D. Degree, Organic Chemistry, Emory University, Atlanta, GA

B.S. Degree (Magna Cum Laude), Chemistry, North Carolina Central University, Durham, NC