SPDS ERP Review-May 2015

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WATSON PHARMACEUTICALS, INC., (ACTAVIS) Corona, CA 2006 - 2009 $2.5B developer, manufacturer, and distributor of generic and brand pharmaceuticals Manager, Analytical R&D Managed raw material release group of 5 scientists. Met aggressive release time frames 100% of the time while ensuring team activities fulfilled company standards and regulations. • Evaluated raw material excipients testing and release requirements, provided technical advice to formulators, and electronically authored hundreds of specifications and test methods for timely release for use in experimental, pilot, and exhibit batches. • Provided Chemistry, Manufacturing, and Controls (CMC) ready documentation to regulatory affairs for ANDA submissions and deficiency responses. • Provided support for pre-approval inspections (PAI) • Redesigned and oversaw system for reference standard procurement, inventory, and qualification which received commendation from the FDA during multiple Preapproval Inspections (PAI) • Served on JD Edward Materials Management System cross-functional implementation team. SOFT GEL TECHNOLOGIES, INC., Commerce, CA 2002 - 2006 Private, global contract manufacturer and distributor of soft gelatin capsule dietary supplements Manager, Quality Control Managed laboratory of 10 members. Supported testing, release, stability activities for 6-day manufacturing operations. • Served as lead in build out of brand new 5,500 square foot laboratory in compliance with local, state, and FDA regulations. • Advised customer service and global sales team in regulatory issues and customer complaint responses ensuring improved customer relations. • Standardized systems which met requirements for foreign and domestic regulations resulting in increased consumer confidence. • Assessed all retained contract laboratory testing capabilities by performing on-site audits ensuring the highest compliance level for outsourced testing. BAXTER BIOSCIENCE, CORP., Los Angeles, CA 2001 - 2002 $5.3B global manufacturer of plasma-based and recombinant proteins and plasma based therapies Manager, Chemistry Managed quality control chemistry laboratory of 20 analysts. Supported testing and release, activities for 24/7 manufacturing operations. • Used LIMS to prioritize, scheduled and track workflow, ensuring timely reporting and completion of lab results. • Presented project summary data to the Management Review Board, ensuring continuous improvement goals were on target. ALPHA THERAPEUTIC CORP. (GRIFOLS USA, LLC) Los Angeles, CA 2000 - 2001 A €121.7M Global developer of blood and plasma therapies Manager, QC Chemistry Managed cGMP/GLP quality control laboratory of 20 analysts. • Enforced strict cGMP compliance under Consent Decree. • Managed resources which resulted in prompt reporting of results. MERLE NORMAN COSMETICS INC., Los Angeles, CA 1999 - 2000 Private developer, manufacturer, and distributor of skin care and cosmetic products in US and Canada Senior Chemist, Analytical/Quality Control Supervised laboratory activities for stability, raw material and finished product release for foreign and domestic markets under strict cGMP compliance. • Developed HPLC and GC methods, authored SOPs, created a log system to track samples, trained subordinates in wet chemistry, instrumentation, and managed laboratory budget.