Well-grounded pharmaceutical scientist and manager in analytical chemistry, from API manufacture, testing, and characterization through final drug product release, packaging, and stability. Thorough knowledge of ICH/FDA/EMA/Japan guidelines, USP, GMPs, GLPs, QA investigations, and method validation/transfer. Authored significant portions of CMC analytical sections for 4 NDA’s, a JNDA, many IND/IMPD filings, and responses to agency questions. Experience working with both CRO/CMO’s and internal resources. Effective manager, including hiring, directing, and developing analytical chemists.Over 7 years leading global CMC teams in matrix organization, delivering aligned strategies, product development milestones, clinical supplies, and regulatory filings. Demonstrated initiative in drug product definition, QbD, and formulation/process development. Consistently outstanding team project management, including project plans, budgets, resources, risk assessment, agendas, virtual meetings, minutes, management summaries, facilitation, and team building.Proactive cross-functional drug development team member representing CMC and providing input to overall program direction. Specialties: CMC, API, drug substance analytical, HPLC, method development, characterization, parenteral and solid oral dosage forms, formulations, process development, small molecules, controlled release, and pediatric formulations. Also, cross-cultural communication, option/decision analysis, brainstorming facilitation. QbD, QTPP, risk assessment, and DOE. Project management, Microsoft Project, strategic thinking, cross-cultural communication (esp. Japan), option/decision analysis, and brainstorming facilitation.