MAJOR ACCOMPLISHMENTS: • Improved, optimized and simplified major bioluminescence assay to improve testing ruggedness, decrease workflow time and refine assay applicability. Applicable to ~80% of all products tested.• Established a fully functional analytical laboratory including lab design, equipment purchases, installations and qualifications (FTIR, HPLC, Multi-mode well plate analyzers, AA) and authored necessary operational SOPs.• Developed, implemented and maintained analytical reference standard program to assure material integrity for use in accurate data quantitation.• Implemented robust analytical test methods for ‘critical to quality’ LC separations to improve product characterization understanding.SELECT RESPONSIBILITIES:• Develop assays for characterization and evaluation of (small molecule) reagents used on DNA pyrosequencing and next generation platforms.• Compose and execute method validation protocols to demonstrate analytical method performance characteristics.• Presented analytical findings to cross-functional audiences and suggest alternate testing routes for improved product quality and consistency.• Streamlined interdepartmental HPLC assays via conversion to UHPLC platform for improved turnaround time and lean workflow (realized up to ~75% time reduction).• Perform advanced product troubleshooting (OOS) investigations and establish correlative data.• Provide analytical support for R&D on next generation product development.• Establish product specifications and compose specifications, technical documents and reports.• Train and mentor junior analytical staff members.

•Established and wrote analytical test methods for support of preclinical drug formulation development.•Worked closely with formulators to support development of new drug products.•Validated HPLC and dissolution test methods for use in proof-of-principle (POP) clinical supply testing.•Organized and performed clinical stability testing for Investigational New Drug (IND) application support.•Composed method development reports and method validation protocols and reports to support drug development and NDA (new drug application) regulatory submissions.•Established standard operating procedures (SOPs) to improve efficiency and compliance of lab operations.•Supported Empower 2 Software as a Laboratory Administrator, supported successful conversion from ChemStation to Empower 2 laboratory environment.•Promoted a team environment with open sharing of ideas and information between formulation and analytical testing personnel.•Employed knowledge of cGMPs (current Good Manufacturing Practices) in work practices to ensure compliance with federal regulations and guidance.

• Developed analytical test methods for drug products, drug intermediates and raw materials including HPLC, GC, titration and physical testing methods.• Composed SOPs, test methods, technical documents and method development reports. • Trained new analyst and technicians on test methods and instrumentation.

• Optimized analytical HPLC and Dissolution Methods for Phase II&III drug product testing.• Investigated, troubleshoot and resolved suspect and out of specification (OOS) test results. • Coordinated and performed analytical testing of pre-clinical, Phase I, Phase II and Phase III drug products and drug substances to support New Drug Application (NDA) submissions.• Accomplished instrument installation, operation and performance qualifications (IQ/OQ/PQ).• Composed and updated Technical Reference Documents (TRD) and Standard Operating Procedures (SOP).• Operated, repaired, maintained and calibrated HPLC systems to reduce equipment costs.• Adhered to stringent GMP and safety requirements; participate in daily safety and GMP meetings.• Performed consistent quantitative, qualitative and stability testing on intermediates and drug products including solid dosages, parenterals and lotions.