Responsible for all CMC activities for drug substance and drug product, including pre-formulation, formulation development, analytical method development, process development, clinical supply, and CMC strategy.

Analytical Operations, responsible for QC and Stability of Commercial Products

Quality Product Leader for small molecules/antibody drug conjugates with responsibility for Quality Assurance and GMP (Phase 1-III)• Represent Quality to Technical Development Teams/Sub teams• Change Control• Deviations and Investigations• Specifications for API, Drug Product, Starting Materials, Intermediates• Analytical Methods and Validation• Certificates of Analysis• Stability studies supporting storage conditions and retest date assignment• Product Specification File• Coordinate with the Qualified Person (QP) for QP Declaration and Release of IMP’s• Regulatory compliance• Trackwise• Review of IND and Q-IMPD sections for Quality• Review of Quality Agreements and GMP Audit Reports for CMOs• Technology transfer for process (API and Drug Product) and analytical methods

Responsible for formulation development, including solid oral dosage formulations and clinical supplies for preclinical and clinical studies (Phase 1, 2). Represented the department to internal project development teams, and Pharma Partnering due diligence teams to evaluate potential in-licensing opportunities.

Overall responsibility for CMC and development of NCE’s from Lead Selection through preclinical evaluation and entry into Phase 1/2 clinical studies. Associate Director for Development Pharmaceutics consisting of functional groups in Analytical Development, Formulation Development, and Pilot Plant Operations. Emphasis on preclinical characterization, preformulation and formulation of peclinical and clinical supplies for NCE’s from discovery through Phase 1/2.

Responsible for CMC activities in support of physicochemical properties, preformulation, formulation and analytics activities in support of lead optimization lead selection, preclinical and phase 1, 2 clinical studies.

Responsible for drug product analysis, analytical method development and validation, release and stability analysis in support of clinical trial materials and registration studies for IND and NDA, Contributions to Naprosyn®, EC-Naproxyn®, Anaprox®, Aleve®, Ticlid®, Ketoroloc IV®, Ketorolac Oral®, CellCept®, Cytovene®.