Pharmaceutical Process Research Consultant: Synthesis and Process for API, Controlled Substances and Platinum Compounds

Expertise

• Pharmaceutical process research and development.
• Development of active pharmaceutical ingredients (API).
• Organic synthesis, including platinum chemistry, synthesis of controlled substances, cannabinoid, opioid and heterocyclic chemistry.
• Terpene chemistry, amino acid, carbohydrate chemistry, organometallic chemistry and asymmetric synthesis.
• Good manufacturing practice (GMP) for pharmaceuticals.
• Seventeen years of pharmaceutical process research and development.
• Research experience includes: Asymmetric synthesis, organometallic catalysis, platinum coordination compounds, controlled substances, anti-tumor compounds, cannabinoids, carbohydrates, terpenes, opioids, heterocycles, amino acids, small ring systems, hypervalent iodine compounds, API manufacturing, chemical structure databases, NMR structure determination.

Experience

Independent Consultant, 2009 - Present

Projects

Merck & Co., Inc., Rahway, NJ, Senior Research Chemist

• Conducted preclinical pharmaceutical process research and development.
• Helped improve the process for β-lactamase inhibitor MK-5034.

Senior Analyst and Chemical Registrar

• Responsible for analysis and quality control of chemical structure data in the Merck chemical structure database, in support of worldwide drug discovery.
• Utilizing four different proprietary software interfaces to Merck's database, used computer programs including ChemDraw, ISIS Draw, Symyx Draw, Chem Sketch, SDF Viewer, and Excel.
• Resolved numerous requests for help from Merck scientists in entering, updating or correcting entries in the database.
• Provided excellent customer service as evidenced by many notes of thanks received.
• Investigated possible structure errors on over 1300 peptide compounds in the database, via microfilm, microfiche, laboratory notebooks, Merck's electronic library, the internet, correspondence with scientists, and personal chemistry knowledge.

Camden County College, Blackwood, NJ, Professor of Chemistry

• Taught General Chemistry 101, both lecture and laboratory sessions, to a class of 24 students.

Pennsylvania State University, Schuylkill Haven, PA, Assistant Professor of Chemistry, 2009

• Instructor of Chemistry, organic chemistry (sophomore students).
• Developed and taught lecture and laboratory courses.
• Participated in a project in which a variety of thiazolidinones were prepared.
• Investigated reactions of cyclopropyl halonium ions.
• Investigated preparation and reactions of cyclopropyl aziridines.
• Developed an improved preparation of iodoimine reagent PhINTs.
• Prepared other iodimines using new procedure.
• Investigated new reactions using PhINTs.
• Oxidized a series of thiazolidinones to sulfoxides and sulfones.
• In collaboration with professional staff, performed computations related to the cyclopropyl aziridine.
• Research with undergraduates on an ongoing engineering project to make biodiesel fuel from the cafeteria's waste cooking oil.
• Participated in a research involving hypervalent iodine compounds.

Johnson Matthey Inc., Pharmaceutical Materials, West Deptford, NJ, 1997 - 2008

Principal Scientist, 2008

• Conducted pharmaceutical process research and development, including GMP scale up of controlled substances and platinum compounds in the chemical process research and development group.

Senior Development Associate, 2000 - 2007

• Management and leadership duties of chemical process research and development.
• Project leader for tetrahydrocannibinol (THC), nabilone, dexanabinol, metaxalone, methamphetamine, methyl phenidate, and platinum anticancer drugs oxaliplatin, JM-216 (satraplatin), carboplatin, and cisplatin.
• Invented novel syntheses of anti-emetic THC, and demonstrated novel terpene chemistry.
• Successfully validated process in plant and commercialized.
• Researched, developed, and successfully scaled process for anti-emetic cannabinoid nabilone.
• Successfully scaled process in GMP laboratory.
• Researched new synthetic route to cannabinoid drug candidate dexanabinol. Demonstrated novel route to cannabinoids.
• Researched and successfully developed process for benzodiazepine anti-anxiety drug lorazepam. Validated process in plant.
• Rapidly discovered and developed new process for muscular relaxant metaxalone. Process was validated in the plant and commercialized.
• Supported ongoing plant operations for carboplatin and cisplatin: Improved the carboplatin recrystallization procedure in the plant.
• Successfully validated a difficult process for platinum anticancer drug candidate JM-216 (satraplatin).
• Synthesized a novel platinum compound for activity screening by customer.
• Initiated project to outsource platinum drug intermediates.
• Did an extensive cost analysis of approaches to economical synthesis of D-methylphenidate. From this, researched and developed new syntheses of racemic and chiral methyl phenidate, drastically reducing cost and cycle time of each process from the earlier processes.
• Discovered and demonstrated new process for methamphetamine.
• Discovered and demonstrated new process for benzphetamine.
• Supervised changes in the manufacturing process for amphetamine.
• Invented and developed a new, very simple process for purification of morphine from concentrated Poppy Straw (CPS), drastically reducing cost and cycle time from the earlier process. Process was validated in the plant and commercialized.
• Rapidly discovered and developed a new crystallization procedure for hydrocodone, and discovered new polymorph.
• Invented new synthesis of oxycodone from 14-hydroxycodeinone.

Stringer, Chemical Engineering Magazine, Chemical Week Associates, New York, NY, 1997 - 2002

• Wrote, edited articles, consultant to other authors, and gave scientific advice.

Bristol-Myers Squibb Co., Senior Scientist, Syracuse, NY, 1991 - 1996

• Conducted pharmaceutical process research.
• Invented, successfully developed and scaled new synthetic routes to the important anti-tumor drugs etoposide phosphate and etoposide.
• Oversaw technology transfer to Swords, Ireland facility.
• Helped develop the process for the anti-coagulant ifetroban.
• Worked on processes for the amino acid derivative, eflornithine and the ACE/NEP inhibitor omapatrilat.

University of Delaware, Teaching Assistant, Newark, DE , 1986 - 1991

• Teaching Assistant - Taught laboratory sections in General and Organic Chemistry. Also tutored students and assisted in exam proctoring and grading for the corresponding lecture courses in a five year span.

Honors & Publications

Professional Activities and Special Interests

• American Chemical Society - ACS, Chair
• American Chemical Society Petroleum Research Fund Undergraduate Research program, Reviewer
• Organic Preparations and Procedures International, Referee

Interests

• Experience in journalism and writing: The Washington Post, Washington, DC, News Aide
• Parsons Peebles Electric Products, Cleveland, OH, Engineering Aide, Provided calculations and drafting, and provided general assistance to the engineering department.

Awards

• Excellence Award, Bristol-Myers Squibb Co., Syracuse, NY.
• University Excellence in Teaching Award, University of Delaware, Newark, DE
• Byrne Thurtell Burns Memorial Award - Provided the greatest proficiency in organic chemistry as demonstrated by a written examination, George Washington University, Washington, DC.

Publications and Patents

• Over 16 Publications for, lectures, and posters, symposiums, and peer reviewed journals.
• 8 patents.

Education

• Ph.D. Organic Chemistry, University of Delaware, Newark, DE
• B.S. Chemistry, George Washington University, Washington, DC