Quality Control Development

CRAIG EPPOLITO

**** **** ****** ****.

Apex, NC *7523

845-***-**** **********@*******.***

SUMMARY

Senior Analytical Chemist with over 10 years experience in chemical development for the pharmaceutical industry. Recognized for method transfer and validation in support of Analytical R&D and R&D to meet Abbreviated New Drug Application filing needs. Extensive knowledge in analytical chemistry and gas chromatography. Collaborative team member and instructor for colleges.

PROFESSIONAL EXPERIENCE

NOVARTIS V & D, Holly Springs, NC MAY 2011 – Present

Chemist (Quality Control)

Perform QC testing in support of manufacturing

• Perform testing for raw materials, and chromatography for flu cell culture.

PATHEON INC., Morrisville, NC Aug 2010 – May2011

Chemist (Pharmaceutical Development Services)

Perform method development, method validations, method optimizations and inter-laboratory qualifications for contract clients. Communicate with clients to meet their product and development needs in a cost efficient and timely manner.

• Execute complete validations for multiple products, including composition of protocols, methods and reports.

• Performed method development and optimization to reduce client cost by decreasing reagent volume and sample analysis time.

• Plan and research all equipment, reference standards, reagents and manpower necessary to complete client projects.

TEVA PHARMACETICALS (FORMELY BARR LABS), Pomona, NY Mar 2001 – Jan 2010

Senior Chemist

Performed quality control testing in regard to raw materials, finished products, and stability samples. Responsible for method transfer, method evaluation and optimization. Analyzed a multitude of pharmaceuticals for international sale.

• Executed assay, impurity, identification and wet chemistry analysis including GC calibration, HPLC trouble shooting, protocol and report composition for the release of quality products to customers.

• Performed alternate process evaluations for vendor materials and cleaning validations.

• Lowered lab supply costs by $10,000 over 7 years by instituting a digital camera system for use in the documentation of Thin Layer chromatography.

CRAIG EPPOLITO PAGE TWO

• Provided on call, in-process particle size analysis, resulting in immediate release of a highly profitable teratogen.

• Reduced inventory backlog with minimal deviations through inter-departmental training.

• Selected for a special project team to implement general method and precision testing for compliance regarding residual solvents for USP (July 1, 2008 deadline).

• Analyzed active pharmaceutical ingredients to demonstrate method validation and equivalency.

• Trained new employees on SOP’s, equipment usage and analytical testing including GC and HPLC. Planned and distributed work assignments with lab partners.

• Drug Enforcement Agency trained to perform testing on controlled drugs class I thru IV.

INSTRUMENTATION LABORATORIES, Orangeburg, NY Jun 1999 – Mar 2001

Formulation Technician II

Prepared and analyzed large-scale bulk products for use as standards in blood analysis machines.

• Analyzed and revised standard procedure methods used for the direct manufacture of product.

• Trained to use formulation equipment including pH meters, homogenizers, centrifuges, drum pumps and rotovapors to produce recombinant tissue and brain thromboplastin control standards.

• Trained in the proper disposal and handling of human plasma as well as other biohazard waste material.

EDUCATION

B.S., Chemistry, State University of New York at New Paltz, New Paltz, NY

Vice-President, Xi-gamma chapter, Kappa Sigma Fraternity

PROFESSIONAL DEVELOPMENT

Member of the American Chemical Society

USP certified for dissolution and method development.

Trained on HPLC by John Dolan from LC/GC publication.

TECHNICAL SKILLS

Analytical Instrumentation HPLC, GC, dissolution, FT-IR, Ion and RI Chromatography, thin layer chromatography, NIR, wet chemistry, auto titration, Karl fisher, coulometric titration and UV-VIS spectrometer. CGMP, MSDS, health and safety and USP/NF standards.

Computer Gxpharma, Excel, LIMS, Trackwise, Empower, Totalchrom, UV-Win Lab, Omnic and Microsoft Office

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