Lead the analytical strategy, development and optimization to drive and integrate innovative plans in alignment with evolving cross-functional and project team goals. Execute the management of the in-house analytical lab, strategic vendor partners, technical and operational from contract negotiation to management activities in collaboration with external CROs and CMOs ensuring high standards, compliance and operations under regulatory and voluntary cGMP requirements for Pharmaceutical characterization and development. • Built the analytical/bioanalytical lab from inception to voluntary cGMP level of compliance accommodating multifactorial dysregulated metabolism research, product development and quality control. Execution resulted in exceeding metrics that facilitated multiple Certificate of Analysis for multiple products that allowed for moving ahead with three clinical safety trials. • Drove the development of a bioanalytical multiplexing assay that was validated at two CROs sites that met a key strategic goal. Allowed for simultaneous targeting of 20 analytes in a single clinical trial sample achieving a reduction in time and cost estimated at $500K for PK analyses for two critical clinical programs.• Developed novel mechanism-based LCMS assay and cGMP-compliant assays resulted in simultaneously meeting both business development and product development goals. CMC Project Management and Resource Optimization/Allocation to support clinical and non-clinical collaborations resulted in meeting aggressive time-sensitive R&D goals.• Experimentally uncovered a novel chemical degradation mechanism of active ingredients in solid phase. Successful risk and mitigation planning resulted in the continuation of a critical clinical program. This Novel chemistry formed the basis of a deeper collaboration and achieved a prototype showing a reduced degradation rate of the active ingredients saving substantial time and cost reductions.

Successfully built the Biologics arm of the company with an R&D focus that became a separate business unit – Heparin-Based Therapeutics. Led Executive-level oversight and strategic planning to establish an effective technology base to drive project objectives and conceptualize new products and technology initiatives. Managed an annual operating budget of $2M -$10M. • Based on the 2008 adulteration of Heparin Drug Substance/Drug Product, modernization of heparin/enoxaparin analytical potency assays met new USP/FDA requirements. This activity drove the creation of business opportunities and allowed for in-depth analysis of the heparin market in China.• Developed CMC strategy to re-engineer a 20,000L large scale process for the extraction and purification of Heparin from pig intestinal mucosa in collaboration with Smithfield Foods, facilitating a heparin material of higher potency/purity. Successful optimization also resulted in commercialization of a NantPharma brand of crude heparin product. • American Pharmaceutical Partners - successful acceptance by the FDA of an antimicrobial drug product without a single analytical deficiency highly contributed to sustainable financial revenue steams that led to the $multi-billion purchase of the company. • Abraxis Bioscience - executed a Biosimilars program (Enoxaparin, GCSF) that was a contributing factor to a buy-back position following a second $multi-billion purchase of Abraxis Bioscience that allowed for the start of the NantPharma Heparin business.