Quality Assurance Supply Chain

KURT R. STICKLEY

*** ***** **** ***** 740-***-**** (HOME)

Granville, OH 43023 740-***-**** (CELL)

************@***********.***

QUALIFICATIONS

Experience managing a quality control, quality assurance and sanitation department for a chemical manufacturer of dietary supplements and fine chemicals

Experience managing pharmaceutical supply chain for medicinal chemistry

Experience in pharmaceutical API process, development, scale-up and manufacturing

Working knowledge of FDA regulatory and cGMP guidelines for the manufacture of Active Pharmaceutical Ingredients (API’s) and dietary supplements

Experienced with kilo lab, pilot plant and production scale syntheses

Management of projects from conception to commercialization

Proven record of process innovation, development and scale-up from bench to multi-ton manufacturing

Proficient with current spectroscopic (IR, ESR, electrochemistry, X-ray crystallography, UV-vis, NMR, DSC), separation (HPLC, SMB chromatography, distillation, chiral resolution), and analytical techniques (GC, GC-MS)

EDUCATION

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

PROFESSIONAL EXPERIENCE

Organic Technologies, Coshocton, OH 2009-present

Director of Quality. Direct department reports include quality assurance, quality control and sanitation. Daily responsibilities include: Working to improve the overall quality management system 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. Experienced in compliance with federal 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.

SKILLS

Computer Literacy

Macintosh, PC; Microsoft Word, Microsoft Excel, Microsoft Power Point, ChemDraw, SciFinder, Minitab

Communication (Oral/Written)

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

Problem-solving/trouble shooting

Member Asian vendor trouble solving initiative

Completed Green Belt training (6-Sigma)

Trained in Design of Experiments (DoE)

PRESENTATIONS/PUBLICATIONS

Process Enabling and the Scale-up of 6- -Hydroxymethylsulbactam and Its Esters T. Norris, et al.

Org. Process Res. Dev. 2005, 9, 432-439.

Triamino-s-triazine Triradical Trications. An Experimental Study of Triazine as a Magnetic Coupling Unit. T. D Selby, K. R. Stickley, and S. C. Blackstock, Org. Let. 2000, 2, 171.

Preparation of Cycloalkylacetylene Compounds K. R. Stickley and D. B. Wiley, US Pat. 5,952,537 and 6,303,057 1999.

Isolable Polyradical Cations of Polyphenylenediamines with Populated High-Spin States. K. R. Stickley, T. D. Selby, and S. C. Blackstock, J. Org. Chem. 1997, 62, 448.

High-Spin Polycations of a Triaminobenzene. K. R. Stickley and S. C. Blackstock, Mol. Cryst. Liq. Cryst. 1995, 272, 81.

Triplet Dication and Quartet Trication of a Triaminobenzene. K. R. Stickley and S. C. Blackstock, J. Am. Chem. Soc. 1994, 116, 11576.

Cation Radicals of 1,3,5-Tris(diarylamino)benzenes. K. R. Stickley and S. C. Blackstock, Tetrahedron Lett. 1994, 36, 1585.

Toward Stable High-Spin Nitrogen-Based Poly Organic Radical Cations: 1,3,5-Tris(diphenylamino)benzene and Its p-Substituted Derivatives. K. R. Stickley and S. C. Blackstock, American Chemical Society 208th National Meeting, Washington, DC, August 21-25, 1994.

ACTIVITIES/INTERESTS

Running, Swimming, Bowling

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