GARY LEE FENNIMORE

**** ******** *****

Indianapolis, Indiana 46268

317-***-**** email: ac8lr3@r.postjobfree.com

Accomplished, detail-driven professional that is dedicated, innovative with a very diverse scientific, consulting and management background. Seeking a challenging position in managerial or technical consulting fields in which I can serve my potential employer to the best of my skills and abilities. Open to relocation.

WORK RELATED SKILLS

Technical Writing Gas, Liquid and Ion Chromatography cGMP/GLP Experienced

Project Management X-ray and Laser Diffraction Experimental Design and GAP

Process Development Spectrophotometry (IR, FTIR, Mass) Calorimetry (DSC, DMA)

Corporate Consultant HPLC and GC Mass Specs. Auditing Pharmaceuticals

FDA Compliance Scanning Electron Microscopy Method Developments, Transfers Supervisory Skills Statistical Analyses (Excel, JMP) Small/Large Molecule developing

CAREER HIGHLIGHTS

Oxford Global Consulting Division for Regulatory and Compliance 2017-18

Contract Consultant on Medical Device Methods and Protocols for Alcon/Novartis QA in WV

Investigate, run and resolve Lab instruments malfunctions and new method resolutions

Write protocols, run methods and evaluate those lab assays for transference to other sites

Troubleshooting GC and GC-HS instruments while developing new methods on them

Oxford Global Consulting Division for Regulatory and Compliance 2016

Contract Consultant on FDA Compliance and Methods at Pegasus Laboratories, Inc. Pensacola, FL

Revising specifications, SOPs, methods and validations for a new product and transfers

Advising for new API and raw material choices from various vendors’ specifications

Create and test new methods, validations, consulting on API, raw materials and reagents

Consultant for LC, GC, IR and raw material method developments and cleaning validations

Oxford Global Consulting Division for Regulatory and Compliance 2015

Contract Consultant on FDA Compliance at Virbac Animal Health Pharmaceutical Co. St. Louis, MO

Advising on method remediation, validations and FDA compliance issues

Validating IT systems calculations retrospectively for regulatory compliance

Labor cost analyses for product laboratory analysis staffing needs

Aerotek Scientific Staffing Services for Vertellus Speciality Chemicals Co. 2012

Analytical Development Chemist on contract, Indianapolis, IN

Infrared Spectrometry and HPLC analyses, repair and troubleshooting instruments

Documentation for European REACh certification

UCB Generic Pharmaceuticals, for c-GMP Quality Control 2009 - 2012

Analytical Development and Operations Chemist, Quality Control, Seymour, IN

c-GMP lab operations, technical report writing, methods, auditing methods for USP compliance and documentation for use in FDA regulatory documents

Modified and wrote technical analytical methods from API manufacturers for routine use in Generic finished product development and quality control

HPLC, Dissolution, Water content and overall instrument troubleshooting for the manufacturing project teams of generic drug products

Pharmaceuticals Material Science methods development and consultant.

Eli Lilly and Company, Analytical Development and Research Laboratories 1995 - 2008

Senior Analytical Development Associate, MSPC and Analytical Development- cGMP/GLP

Tippecanoe Laboratories in Lafayette, IN and Corporate Technology Centers in Indianapolis, IN

Pharmaceutical Solids Analyses and the advanced interpretative skills to elucidate from many MSPC instruments the physical properties, the particle size and crystal forms or amorphous characterizations of pharmaceuticals that were used for final product formulation improvements

Directly participated on a MSPC special project team that oversaw the changes to the process chemistry that produced the critical crystal form changes measured by x-ray crystallography. The eventual corrective formulation design changes were implemented for the chemistry processes of the successful pharmaceutical product Effient

Extensive abilities with c-GMP lab requirements, remedial efforts, test method validations and documentation for use in FDA regulatory determinations and documents

Interpreted ICH guidelines for implementation in analytical method developments.

Managed the technical training to new staff and some outside corporate product transfers in the use of analytical instrumentation and established analytical methods

Maintained compliance of computers, the analytical instrumentation and was involved in managing the remedial investigations with HPLC methods along with team actions.

Awarded the Eli Lilly “Changing The World“ award for the foreign team project management and sensitive cleaning extraction method innovations that made billions for Eli Lilly thus enabling the Alimta project team in Fegersheim, France to proceed into manufacturing and marketing of this needed life-saving pharmaceutical

Oversaw a French project team and directed them in the use of these Alimta methods. Directed some method transfers to the Eli Lilly manufacturing site in Fegersheim, France

Managing the analyses of many research and discovery compounds in the pharmaceutical products areas that enabled the sale of some blockbusters Evista, Cialis, Zyprexa, Cymbalta, Alimta, Effient and many others not marketed

Managed the documentation of projects in notebooks, auditing and internal publications that directly were placed into regulatory documentation and used in presentation meetings with government agencies and some were published in scientific journals

Extensive instrument and pharmaceutical method developments, auditing chrome data and troubleshooting using various software (HPLC and GC Empower, and Millenium)

Reviewed resumes, interviewed job candidates, and made hiring decisions regarding staff

Developed and wrote analytical methods for routine use in API developments and quality control published methods and reviewed others work and documentations.

Proficient with many computer software systems (Word, Excel, JMP, Powerpoint, etc)

Automated microbial turbidity measurements, extensive biotechnology technique and managerial experiences in fermentation

Various analyses of five intermediates and the final synthesized API pharmaceutical Evista, methods development, validations and troubleshooting for these analyses

Trained and managed our Japanese colleagues from Seishin Development Laboratory Eli Lilly; Kobe, Japan in transferring various methods that our group developed for Evista

EDUCATION

Purdue University, West Lafayette, Indiana Bachelor of Science degree in Agronomy

Minors: School of Management and Pharmaceutical Sciences

Graduate courses in Soil Classifications, Tropical Agronomy and Pharmaceutical Solids

Completed “Training Masters” courses by Dr. Rayman Wong on HPLC development

Prestigious Evans Scholarship award recipient and Alumnus and Former PGA Golf Professional

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