Project Manager Quality Control
Resume:
N**W***** Vernon Drive . Hartland, WI *****
Phone 1-262-***-**** . E-mail: abnbqs@r.postjobfree.com
Jerome Menzia
Plant Safety Engineer
[pic]
Manufacturing Leadership [pic] Continuous Improvement & Training
New Process Development [pic] Equipment Management
Highly accomplished and talented Pharmaceutical Manufacturing
professional with over ten years progressive experience in leadership
role within a company that demands expertise in all aspects of
operations management, technical transfers, manufacturing,
engineering and new product development. Solid track record of
successful experience includes optimizing productivity, improving
profitability and successfully controlling erratic chemical
processes.
Product Management
Quality Control
Root Cause Analysis
Operations Management
Regulatory Compliance
Customer Relations
Research&Development
Waste Management
APIC,BPIC,ERP Software
Leadership, Training & Teambuilding
Environmental Compliance
Production&Inventory Control
CAREER HIGHLIGHTS
September 2008 to Present J.F. Menzia and Sons, LLC
Milwaukee, WI
General Manager
Managed Purchasing Department
Developed Customer Database for Tracking Quote activities
Project Manager for Quoting
Acting Quality Assurance Manager
February 2007 to August 2008 Cedarburg Pharmaceuticals
Grafton, WI
Study Director/Research & Development Scientist
Independently designs experimentation to achieve control of
critical parameters.
Primary customer contact for weekly scientific updates on assigned
product.
Generate and interpret analytical data to solve quality control
issues during process development.
Extensive technical writing experience with cGMP batch records and
GLP notebooks.
Perform literature and patent searches to achieve technical
competency on projects.
Controlled substance development.
July 2000 to January 2007 Fontarome Chemical Inc.
Milwaukee, WI
V.P. of Operations promoted from Production Manager
Directed the manufacture of custom pharmaceutical intermediates on
plant scale.
Tracked new contract molecules through evaluation and quote.
Responsible Care Coordinator to achieve practice-in-place on SOCMA
initiative.
Established Minimum/Maximum product inventory system based on
historical sales leading to 100% On Time deliveries.
Improved Personnel review process by creating and implementing
performance driven metrics.
Responsible for Environmental compliance with respect to Sanitary
Discharge permit, Air Emissions Inventory and Storm Water Outfall
Permit resulting in favorable compliance.
Obtained a 25 % reduction in production operating cost by
increasing equipment utilization, reducing hauled waste cost and
reduction of cleaning expenses.
Validated three commercial processes for generic bulk API's
Established a safety program including PHA's, OSHA Training,
Equipment Training, Safety Committee and PSM.
Champion for the production of 15 to 25 new products annually,
including generic drugs, pharmaceutical intermediates and flavor
chemicals.
Completed cleaning validation of plant equipment using CIP and
conventional cleaning systems in response to FDA 483.
November 1999 to June 2000 Zeeland Chemical Inc.
Zeeland, MI
Senior Scientist
Team leader for the successful development of potential products.
Liaison to manufacturing for plant startup of new products.
Provided plant layout of a multi step process utilizing 10 pieces
of equipment.
September 1990 to October 1999 Abbott Laboratories
North Chicago, IL
Research & Development Scientist /Process Support Scientist
Process development of the chemistries associated with drug
candidates to supply materials for clinical research.
Generate and interpret analytical data to solve quality control
issues during process development.
Champion for the startup of the generic product Ketorolac
Tromethamine on multi ton scale for which I was awarded
"Engineering Excellence Award" for team excellence.
Process Support for the plant startup of the HIV protease inhibitor
Ritonavir to deliver commercial quantities.
Gained extensive experience in the preparation of Process
Justification Reports, Process Validation reports and NDA / IND
Filings.
Education
1990 University of Wisconsin Milwaukee
Bachelor of Science /Organic Chemistry
2 years undergraduate research with Professor James Cook
References
Anthony Haight Abbott Laboratories
Group Leader
Timothy Stuk
Pfizer Inc.
Research Fellow
Jim Zeller Jim Zeller
Consulting
Owner
616- 485-9102/abnbqs@r.postjobfree.com
Professional memberships
American Chemical Society (ACS)
International Society for Pharmaceutical Engineering ( ISPE)
Patents and publications
Haight, A.R.; Stuk, T.L.; Menzia, J.A. "Process for the
Preparation of Substituted Keto-Enamines" US Patent
5,932,766 Aug 3, 1999
Haight, A.R.; Stuk, T.L.; Menzia, J.A.; Robbins, T.A.;
Allen, M.S.; Bhagavatula, L.; Fitzgerald, M.; Hannick, S.M.;
Kerdesky, F.A.; Parekh, S.I.; Scarpetti, D.; Tien, J.H.J.
"Reduction of an Enaminone : Synthesis of the Diamino
Alcohol Core of Ritonavir", Organic Process Research &
Development 1999
Haight, A.R.; Stuk, T.L.; Menzia, J.A.; Robbins, T.A.; "A
Convenient Synthesis of Enaminones Using Tandem Acetonitrile
Condensation, Grignard Addition", Tetrahedron Letters 1997
Tien, J-H.J.; Menzia, J.A.; Cooper, A.J. "Process for the
Preparation of an HIV Protease Inhibiting Compound" US
Patent 5,567,823 Oct. 22, 1996
Singham, P.R.; Bradshaw, C.W.; Menzia, J.A.; Narayanan,
B.A.; Rockway, T.W.; Welch, N.; Tien, J-H.J. "An Efficient
Process for the Synthesis of Renin Inhibitor, ABT-517"
Synthetic Communications, 26(14), 2751-2756(1996)
Krysan, D.J.; Haight, A.R.; Menzia, J.A.; Welch,N. "A
Stereoselective Synthesis of the Dihydroxyethylene Dipeptide
Isostere, ABT-768" Tetrahedron, 50(21):6163(1994)
Krysan, D.J.; Haight, A.R.; Lallaman, J.E.; Langridge, D.C.;
Menzia, J.A.; Narayanan, B.A.; Pariza, J.R.; Reno, D.S.; .;
Rockway, T.W.; Stuk, T.L.; Tien, J-H.J. "An Improved
Preparation of (S)-N-(Boc)-Cyclohexylalaninal. The
Moffat-Swern Oxidation of a-Aminoalcohols" Organic
Preparations and Procedures Int., 25(4), 437-443 (1993)
Zhang, L.; Bi, Y.; Yu, F.; Menzia, J.A.; Cook, J.M.
"Stereospecificity in the Pictet-Spengler Reaction.
Enatiospecific Synthesis of (6S,
10S)-5-methyl-9-oxo-12-benzyl-6,7,8,9,10,11-hexahydro-6,
10-imino-5H-cyclooct [b] indole, a Template for Preparation
of Macroline/Sarpagine Alkaloids" Heterocycles, 34(3),517
[1992]
Awards received
1999 Chairman's Award "Going above and beyond normal duties"
Abbott Labs
1998 Chairman's Award "Going above and beyond normal duties"
Abbott Labs
1997 Engineering Excellence Award "Team Excellence"
Abbott Labs
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