ERIC WEI

***** *** ** ******* **, Clearwater, FL 33762 727-***-**** x9ggq8@r.postjobfree.com

PROFILE

Professional with extensive hands-on experience in GMP 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 good time management skills.

EXPERIENCE

Bayer Health Care Emeryville, CA

May 2010-Present

Senior Validation Specialist (Consultant from ProPharma)

• Develop IOQ, Requalification, and ePQ protocols for bioanalytical instruments used in analyzing and mapping antihemophilic proteins (ELISA, Waters HPLC, ICS 3000, AKTA, Molecular Devices SpectraMax 384, BioRad GS800).

• Develop method transfer protocols.

• Execute IQ, OQ, and PQ of protocols.

• Generate summary report and submit qualification packages.

• Compose commissioning packages.

BioMarin Pharmaceutical Novato, CA

February 2010-April 2010

Validation Engineer (Consultant from Biokinetics)

• Write equipment verification protocols for equipment used in cell culture and enzyme manufacturing facility: glucose analyzer, filter integrity tester, Cultibags, Vi-Cell Cell Viability Analyzers, tube welders, tube sealers, and ultrasonic cleaning system,

• Perform IQ and OQ of instruments and equipment.

• Coordinate plans and schedules among vendors, building contractors, Engineering department, Validation department, operators, and management.

• Execute protocols and generate final report packages.

• Monitored cold chamber with Temp Tales and Kaye Validator.

Catalent Pharma (formerly Cardinal Health and R.P. Scherer NA), St. Petersburg, FL

September 1999-October 2009

Validation Chemist/Specialist

• Cleaning Validation: Perform cleaning validation and verification in support of production of pharmaceutical softgels using swab and/or rinse technique: visual inspection; collect samples at various specified sites; prepare and run samples for HPLC or GC testing; interpret data and calculate results; write report; present data to another analyst and QA Manager for auditing ; write Release Memo and release the production equipment for the next product.

• Method Development: Literature research and develop QC analytical test methods for Tipranavir and Estradiol; literature research and develop Cleaning Validation analytical methods for numerous products, often in the nanogram range, including Cyclosporine, Targretin, Norvir, Ergocalciferol, Accutane, Zemplar, Rocaltrol, detergents, and many other cough/cold and nutritional products.

• Cleaning Validation Research: Develop cleaning validation analytical methods; perform linearity, specificity, accuracy, and ruggedness tests; perform recovery tests off various contact surfaces such as stainless steel, chrome plated stainless steel, tool steel, viton, borosilicate glass, aluminum, teflon, HDPE, etc.; write protocols, reports, SOP’s, conduct method transfers and qualification, training, scheduling, laboratory equipment troubleshooting.

• Process Validation: Evaluate fill moisture after different drying intervals for optimum drying time; evaluate mixing speed of the fill material; evaluate dye and ink level for targeted color; evaluate gelatin viscosity.

• Equipment Validation: perform IQ-OQ-PQ of LC's, GC's, and Dissolution systems.

• Manufacturing Equipment Validation: OQ and PQ of mixing vessels of various sizes, reactors, Becomix, double boilers, encapsulation equipment, and Girton washers.

• R&D: Formulation---excipient and PAI volume and stage, mixing speed, 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. Studied various membrane filters for optimum filtration and purification.

• 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.), (Perkin-Elmer, Waters, Shimadzu), Gas Chromatography (FID), 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-September 1999

Chemist

• 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.

• Write IOQ verification protocols for new laboratory instrument.

Thornton Labs, Tampa, FL

August 1990-March 1992

Chemist

• QC: Perform tests on pharmaceutical, fertilizer, agricultural, and food products using Kjeldahl assay, AA, and GC.

EDUCATION

Bachelor of Science in Chemistry 1991

Minor in Economics

New College/University of South Florida

University of South Florida Graduate Program August 1993-May 1994

Synthesized thio-perester compounds for a Ph.D. candidate.

References available upon request.

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