Quality Assurance Process
Resume:
John F. Genus, Ph.D.
**** **** ***** *** 803-***-****
Rock Hill, SC 29732 803-***-**** (cell)
******@*********.***
Work Experience
Targacept Inc., Winston-Salem, NC
Sr. Staff Scientist – Chemical Process Development Team
• General responsibilities included the scale-up synthesis of 11 lead compounds and various
intermediates from multi-gram to kilogram levels for pre-clinical toxicology requirements.
• Developed scaleable processes for cGMP outsourcing on 7 lead compounds in a team environment
up to the kilogram level.
• Provided synthesis support for analytical, medicinal, and CRO groups.
• Served as the CPD representative for the 4-year Astra Zeneca research collaboration.
• Managed all chemistry projects and process lab personnel as interim group leader (3/02-2/03)
reporting to the VP of Research during Director search. Acted as team leader (3/03-3/10) in CPD
managing projects for several chemists (BS/MS/PhD).
• Ran HPLC, LC/MS, GC/MS, and NMR as standard analysis tools on a daily basis.
Merck & Co., Inc., Merck Manufacturing Division, Albany, GA
2/86 - 4/99
Senior Project Scientist - Technical Operations Development Group (3/97-4/99)
• Completed a new Losartan Potassium procedure which increased yields 10% and provided more
throughput (3 to 4 fold). Potential savings up to $50MM annually.
• Completed scale-up and piloting (22L) of Simvastatin pure project. Final product purity was further
increased by 1%. Ran 25 pilot runs at 1 Kg level to demonstrate process.
Senior Chemist/Project Scientist - Technical Operations (1/93-2/97)
• Provided technical support for Cefoxitin, Losartan Potassium, Omeprazole, Simvastatin, and
Indinavir Sulfate processes by trouble-shooting yields and final product quality, evaluating raw
materials, preparing in-process standards and providing factory process demonstration support.
Performed cGMP chemistry training to QO and factory personnel.
• Performed process optimizations to meet departmental Profit Improvement Objectives. Average
annual savings of $1-2MM.
• Fully optimized the Cefoxitin crude/pure steps by devising three cost-saving improvements
totaling $3-4MM. Increased factory yields and productivity by 22%.
• Developed a $12MM improvement for Simvastatin pure. Explored improvements for Simvastatin
ammonium salt utilizing protecting group chemistry.
• Redeveloped the boronic acid step for Losartan Potassium by changing the hydrolysis and wash
procedures. Eliminated a key impurity and improved centrifugation and drying operations. Resulted in
increased production and zero batch rejections.
• Solved a color problem for Cefoxitin by working until the source of the impurities was identified and
eliminated from the process to avoid a factory shutdown.
• Provided chemistry support on the protease inhibitor, Indinavir Sulfate during start-up and solvent
recovery studies.
• Managed four junior chemists, several interns and lab technicians.
Merck Research Fellow - University of South Carolina, Columbia, SC (7/90-12/92)
• Selected as a participant in the Merck Doctoral Program to complete Ph.D.
Staff Chemist - Technical Operations (5/88-6/90)
• Provided support for Cefoxitin, Tocanide Hydrochloride, and Simvastatin processes.
Improved Tocanide Hydrochloride chemistry during initial factory demonstration.
• Participated in Process Development Group “Make vs. Buy” chemistry. Generated $3MM savings on Enalpril
Maleate. Piloted to 30 liter batch size.
• Devised a revised four -step alternate solvent process for Cefoxitin to reduce methylene chloride
emissions. Improved initial yield from 15% to 58%.
Genus/p2
Assistant Chemist - Technical Operations (6/86-4/88)
• Supported senior chemists on Cefoxitin and Methyldopa processes by running use-tests,
factory front-runs and trouble-shooting experiments.
• Assisted chemistry section head with synthetic work on Cilastatin, Enalpril and Cefoxitin
raw materials and intermediates.
Control Chemist - Quality Control (2/86-5/86)
• Ran all in-process and final product HPLC assays for Cefoxitin.
E.R. Squibb & Sons, Inc., New Brunswick, NJ
1/81 - 12/81
Chemist Assistant - Analytical Development Group
• Performed HPLC assays on factory in-process and final product samples.
• Assisted in impurity elucidation (IR, TLC and optical rotation).
• Ran quality assurance assays on final products and overchecks on technician results.
Education
University of South Carolina, Columbia, SC
7/90 - 12/92
Ph.D in Organic Chemistry
Thesis: Synthetic Methodology Directed Towards the Diterpene Antifeedant Hardwickiic Acid
Graduate Research Director: Thomas A. Bryson, Ph.D.
8/82 - 8/85 M.S. in Organic Chemistry
Thesis: The Catalytic Decarbonylation of Aldehydes via Cationic Ir and Rh (I) Complexes.
Trenton State University, Trenton, NJ
9/78 - 5/82
B.S. in Chemistry
Additional Training & Achievements
• Inventor on several U.S. Patents for Targacept and Merck compounds.
• Published Papers:
1) Genus, J.F.; Peters, D.A.; Bryson, T.A. Synlett, 1994, 3, 209.
2) Genus, J.F.; Peters, D.A.; Bryson, T.A. Synlett, 1993, 10, 759.
3) Several Targacept Papers submitted for publication.
• Presentations:
1) Ethyl Benzyl Pyruvate Optimization, Merck & Co. - Make vs. Buy Meeting,
Rahway, NJ, June 1990.
2) Cefoxitin Alternate Solvent Chemistry Highlights, Merck & Co. - Technical
Operations Strategy Meeting, Rahway, NJ, June 1995.
3) One-Step Simvastatin Pure From Ammonium Salt - Merck & Co. Technical Operations
Annual Meeting, Rahway, NJ, December 1996.
• Trained Recruiter/Interviewer (Merck & Co., Inc.)
• Seminars:
* Statistical Experimental Design
* Solid State Chemistry - SSCI/Aptuit
* Practical Process Research and Scale-Up - Neil Anderson Process Solutions
* Varian NMR Training
* cGMP Training Monthly/Annually
* Covey Principle Centered Leadership
* Leadership Effectiveness Training
* FT-NMR Training, Virginia Technical Institute, Blacksburg, VA
• 2005 Targacept Spot Award for 2216-232
• 1996 Merck Award for Excellence - Losartan Potassium (Boronic Acid Improvements)
• 1990 Merck Award for Excellence - Cefoxitin (Alternate Solvent Work)
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