SPDS ERP CVs - DEC 2017

• Directed raw material and finished product testing for pharmaceutical, biopharm, and medical devices. • Directed stability studies for medical devices (drug eluting stents) and pharmaceuticals

(transdermal, injectable, parenteral, ophthalmic, and tablets). • Impurity profiling of small molecules and biopolymers. Watson Pharmaceuticals, Inc. (Corona, CA) Associate Director, R&D

Jul. 2004-Feb. 2009 Jul. 2001-Jun. 2004

Manager, R&D Supervisor, R&D

Aug.1999-Jun. 2001 • Successfully developed 24 + generic solid dosage form drug products for abbreviated new drug applications (ANDA) filings and drug substance DMF filings. • Evaluated, developed and validated generic drug methods used in, and the controls for the design and manufacture of drug substances and drug products. • Extensive experience with FDA’s QbD, QbR, QOS for ANDA or amendments and supplemental applications to ensure appropriate reporting of the chemical components, manufacturing, processing, control, stability, and labeling. • Obtained FDA approvals on product commercialization including first to file and Paragraph IV filing. Responded deficiency letters to obtain product approvals. • Facilitated FDA on-site inspection for pre-approval cGMP audit with no 483 observation. • Managed four teams of analytical development about 30 + R&D scientists with B.Sc. M.Sc, and PhD degrees to be efficient with high standard of performance. • Actively oversees programs at contract research organizations to ensure the activities are completed on schedule and resolve any technical issues to meet project and budgetary goals. • Strategic planning and execution for different phases of new drug product/drug substance development from conceptual to commercialization (strategy design, vendor selection, formulation development, clinical release, stability, CMC filing, technology transfer, and commercialization). • Managed activities of drug product evaluation/reverse engineering, stability, method development and validation for drug substances and drug products (Immediate release and extended release tablets/capsules and transdermal products). • Expertise in trace analyses, bio-relevant dissolution methods (USP apparatus I, II, III, IV), and setting specifications for RM and finished product. • Acquired, qualified and applied modern instrumentation for the R&D work (HPLC, LC/MS, GC, GC/MS, TLC, AA, IR, UV/Vis, Fluorescence, Andersen Cascade Impactor (ACI), Next Generation Impactor (NGI)). • Physical characterization using particle size analysis by Malvern Mastersizer, hot stage microscope, DSC, TGA, SEM, chemical imagining NIR, XRD, and Raman.

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