KURT R. STICKLEY
Granville, OH 43023 740-***-**** (CELL)
Working knowledge of FDA regulatory and cGMP guidelines for Active Pharmaceutical Ingredients (API’s), foods and dietary supplements
Experience managing a quality control, quality assurance and sanitation department for a manufacturer of food ingredients, dietary supplements, direct to consumer products and fine chemicals
Experience managing internal and external customers and suppliers
Experienced with kilo lab, pilot plant and production scales
Management of projects from conception to commercialization
Proven record of process innovation, development and scale-up from bench to multi-ton manufacturing
Knowledgeable in food, dietary supplement and API regulatory compliance
Knowledgeable in ISO 9001, 22000 standards
HACCP/FSPCA (Food Safety for Preventative Controls) Certified
Ph.D. in Organic Chemistry, Vanderbilt University, Nashville, TN
M.S. in Organic Chemistry, Vanderbilt University, Nashville, TN
B.S. in Chemistry, Grove City College, Grove City, PA
Organic Technologies, Coshocton, OH 2009-present
Director of Quality Assurance. Direct department reports include quality assurance, quality control and sanitation for an NSF certified food and dietary supplement manufacturer. Daily responsibilities include: Working to improve the overall quality management system (QMS) and cGMP functions of company products (i.e. Omega-3’s and sterols), Interfacing with the FDA, ODA, supplier, internal and third party audits, Interacting with engineering and R&D to assure a seamless operating environment, Over-sight of analytical test method development for raw materials, in process and finished products, Preparing and reporting on HACCP plans and stability studies for new and existing products, Interacting with external clients to resolve quality issues, Over-sight of continued company-wide cGMP training and education. FSPCA certified. Experienced in compliance with federal and state regulations: 21 CFR 117 (Food Safety Management Act), 21 CFR 111 (Dietary Supplements) and 21 CFR 123 (Seafood HACCP).
Pfizer U.S. Pharmaceuticals, Groton, CT 2007-2009
Senior Scientist. Supply Chain. Daily responsibilities include: Working with Contract Research Organizations (CRO’s) to maintain the inventory of the global chemical supply for discovery chemists. Managing chemical requests as initiated by internal medicinal chemists to be performed at CRO’s (requests range from exploratory to IVT studies). Serve as a general liaison between the CRO and the internal medicinal chemist. Measure CRO’s productivity, timeliness of delivery and problem-solving skills. Providing an overall efficient and frictionless process from request to delivery.
Pfizer U.S. Pharmaceuticals, Groton, CT 1998–2007
Senior Development Chemist. Daily responsibilities include: Managing several laboratory technicians, interacting on a technical level with quality assurance, engineering, outside vendors, and colleagues. Assist with project collaborations both internally and externally and improve, optimize, and support plant processes.
Organic Technologies, Coshocton, OH 1996–1998
Research Scientist. Responsible for the development, scale-up, and optimization of new and known syntheses of natural flavors, specialty chemicals, and pharmaceutical intermediates and for the evaluation of reaction sequences for utility in terms of cost, safety, and environmental friendliness.
Macintosh, PC; Microsoft Word, Microsoft Excel, Microsoft Power Point, ChemDraw, SciFinder, Minitab
Completed course – “Working Effectively with China and India”
Conduct plant tours to local college groups
Presentations in the annual green chemistry community outreach programs
Management and leadership
Manage the compound requests of internal medicinal chemists
Responsible for the daily work activities of laboratory technicians.
Completed long term project – New (Zoloft) Sertraline HCl process
Involvement in Pfizer Green Chemistry program
Able to work in a team environment
Member Asian vendor trouble solving initiative
Completed Green Belt training (6-Sigma)
Trained in Design of Experiments (DoE)
Running, Swimming, Bowling