Professional with extensive hands-on experience in laboratory and field studies. Skilled in a variety of endeavors and able to see projects from acquisition of funding to presentation of data, both independently and as part of a team. Good writing skills. Self-motivated, well organized, and flexible with exceptional time management skills.
Catalent Pharma (formerly Cardinal Health and R.P. Scherer NA), Saint Petersburg, FL
Validation Chemist September 1999 to Present
Validation: Perform cleaning validation and verification in support of production of pharmaceutical softgels, develop analytical methods, validate production process. Responsibilities include writing validation protocols and reports, writing SOP’s, conduct method transfers and qualification, training, scheduling, and laboratory equipment troubleshooting.
R&D: Formulation of products, method of delivery, production process, equipment cleaning, analytical method development, equipment surface recovery studies. Worked with the Pilot Plant. Supported the development of softgel from sea kelp. Supported development of analytical method utilizing liquid nitrogen in softgel assay.
QC: Analyze raw materials, pre-mix fill materials, finished products, stability products, degradation of actives.
Analytical Techniques: Liquid Chromatography (Reverse Phase, Normal Phase, Ion Pairing, Ion Exchange etc.), Gas Chromatography, Spectroscopy (UV/Vis, NMR, Fluorescence)
cGMP Regulations, FDA GLP and ICH Guidelines
Liaison for clients, which include visiting various pharmaceutical companies and coordinating projects.
Train, supervise, and evaluate performance of analysts and production operators on lab techniques and operation of instruments.
Plan and coordinate production schedule and Validation support with the Production Manager.
Computers: PC and chromatography application software (Turbochrom®). Database, spreadsheet and word processor.
QA: audit batch records and QC data.
UDL Labs of Mylan Pharmaceutical, Largo, FL March 1992 to September 1999
QC: Performed a variety of analytical tests and validations employing HPLC, GC, UV-Vis, and FTIR at a large pharmaceutical plant specializing in liquid doses and tablets.
Coordinated outsourced tests and stability studies; prepared reports.
Performed cleaning validation and verification in support of production.
Supported R&D in method development.
Supported ANDA process of two products.
Responsibilities include writing SOP’s for laboratory equipment, IQ-OQ-PQ, method transfers, training, scheduling for production, supervising, and laboratory equipment troubleshooting.
Thornton Labs, Tampa, FL August 1990 to March 1992
QC: Perform tests on pharmaceutical, fertilizer, agricultural, and food products using Kjeldahl assay, AA, and GC.
Bachelor of Science in Chemistry 1991
Minor in Economics
New College / University of South Florida
University of South Florida Graduate Program August 1993 to May 1994
References available upon request