Pharmaceutical Industry Leader with expertise leading large scientific/technical organizations responsible for analytical development, launch, and commercial support for internal and external manufacturing. Known for ability to direct complex programs and consistently achieve deliverables for scope, time and budget. Will apply his analytical expertise, unique breadth of experience, and ability to consistently achieve project deliverables to fulfill client analytical, CMC, or laboratory project needs.ANALYTICAL DEVELOPMENT. Analytical method and specification development expertise to support formulation development, clinical development and marketed product needs. Phase-appropriate method validation solutions and reports.CMC SUBMISSIONS. Author CMC sections for investigational new drug submissions, marketing applications, and post-approval CMC submissions. Technical briefing package preparation and SME representation at FDA meetings.STABILITY STUDIES. Protocol design and preparation for excipient compatibility, forced degradation, research, clinical, registration and marketed product stability studies. Data analysis and study reports.TECHNOLOGY TRANSFER. Experience directing analytical method transfers from internal development to internal manufacturing, CRO to CMO, and CMO to CMO. Manage CRO / CMO project interactions; serve as Technical Team lead/Steering Committee member.LABORATORY OPERATIONS. Partner with Analytical Development or Quality Control laboratory management to support lab expansions, LIMS implementations, staff skills assessments and technical career ladder development.Specialties: • Analytical Development • CMC Submissions• Technology Transfer • Stability• Program Management • Laboratory Operations