Analytical Scientist III, EHS Advisor

Brian M. Gaither

*** ********, ********, ** *****

Phone: 618-***-****

Email: **************@*****.***

Industrial Experience

Analytical Scientist III – Research Group, Fleming Pharmaceuticals, St. Louis, MO (2009-2012)

• Chemistry Project Lead for new product launch of cough syrup products, hydrocortisone creams, and quick dissolving vitamin tablets.

• Performed cGMP audits of component supplier facilities confirming established component integrity and overall supplier performance.

• Performed quarterly audits of laboratory, warehouse, and production areas for safety compliance and determine potential safety or compliance issues.

• EHS management of all laboratory generated liquid and chemical waste including the on-site storage and proper disposal and implemented a chemical hygiene plan.

• Responsible for risk management and safety objectives for both laboratory and warehouse environments, including scheduled training and awareness briefings, with particular detail to slip and fall and entrapment hazards.

• Responsible for auditing of annual laboratory instrument and equipment maintenance and usage logbooks as well as updating MSDS inventory.

• Conducted root cause failure investigations, developed testing protocols, presented all data in reports, and implemented both lab SOPs and EHS solutions based upon findings.

• Wrote and conducted HPLC method validations and laboratory SOPs for in-house and contract development obligations.

• Audited and implemented production line strategies to increase line capacity by 12%.

Analytical Scientist II – Analytical Group, Meridian Medical Technologies, St. Louis, MO (2006-2009)

• Performed numerous HPLC method validations for both new drug development and optimizing existing methods, focused heavily on degredant identification and quantitation.

• Developed anti-nerve agents for allied military forces, with specific formulations and component design requirements conforming to FDA, BP, and JP regulations.

• Conducted EHS audits and compliance reports for laboratory and formulation departments.

• Delivered quarterly project update presentations for departmental Directors, focusing on deadlines, budget, and inter-departmental co-operational efforts to ensure completion of task.

• Acted in advisory capacity during new personnel decisions, laboratory and equipment purchases, and contract work timelines.

Research Scientist II –Research and Development, Meridian Medical Technologies (2002-2006)

• Authored the SOPs for all future HPLC and PDA analysis of samples, operations and maintenance, solvent disposal, and chemical hygiene plan.

• Supervised and conducted installation and qualifications of HPLCs, GCs, volumetric autotitrators, analytical balances, pH meters, and various other standard laboratory instrumentation.

• Responsible for initial stocking and purchasing of chemicals, equipment, and instruments for new R&D laboratory.

• Drafted and executed instrument specific SOPs complete with Waters software compatibility validation.

Brian M. Gaither

503 Archview, Columbia, IL 62236

Phone: 618-***-****

Email: **************@*****.***

Chemist II- Chemical Testing Lab, Meridian Medical Technologies (1999-2002)

• Developed periodic maintenance schedule for laboratory instrumentation, and implemented a HPLC column cleaning procedure, which saved over $15,000 annually.

• Developed and implemented a testing schedule which decreased time-to-test for finished products by 35%.

• Conducted routine cGMP testing of drug products both bulk formulations and stability.

• Responsible for sample identification and data logging.

• Reviewed and updated departmental SOPs.

• Conducted QA inspections under ASQ guidelines and parameters.

Quality Control Chemist – Sherwood Medical, Bridgeton, MO (1998-99)

• Developed a product testing enclosure to increase testing production by 50%.

• Responsible for testing all raw materials used in production of medical devices.

• Conducted specialized testing of finished products to ensure integrity.

• Wrote and update departmental SOPs

Chemist I – American Bottoms Wastewater Treatment Facility, Sauget, IL (1997)

• Prepared analytical standards for use in the testing of heavy metals.

• Performed daily site collection of samples for monitoring.

• Responsible for weekly data report generation of EPA wastewater compliance regarding heavy metals.

Education

Southern Illinois University, Edwardsville, IL

B.S. Chemistry Advisor – Dr. Robert Dixon,

Extensive Industrial Continuing Education on Safety, Technical, Regulatory, Instrument

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