CAREER SUMMARY * Senior, seasoned pharmaceutical R&D professional with strong administrative, strategic & scientific planning, and coordination/execution skills, gained through 27 years of industrial experience in leading CMC technical development function (Pharmaceutics & Analytical), and leading global development & regulatory filings for NMEs (small molecule and biologics / mAb), and 505 (b) (2) products strong expertise in injectable (IV, SC), oral (solid, liquid IR, MR), and topical products * Proven skills and experience in leading CMC technical development function and managing development activities with internal staff and CMOs, including preformulation, formulation and process development, analytical development, clinical supply (CTM), technology transfer, technical CMC regulatory, technical support (to commercial products), and CMC project management groups * Strong expertise in Pharmaceutics support to drug discovery & candidate optimization/selection teams, providing formulation support for DMPK & pharmacology studies and developing enabling formulations for suitable discovery candidates * Demonstrated record of leading multi-disciplinary (API, DP, AD, SCM, QA, CMC-RA) CMC development teams for over fifteen (15) NME programs from early to late stage development, through to market approval experienced in managing development programs with global co-development partners successfully registered five (5) NCE products (oral, parenteral, topical) and supported commercial launch * Experienced in leading CMC technical evaluation in support of BD in-licensing and out-licensing activities * Competent in authoring CMC sections of regulatory documents for clinical trials (IND, IMPD, CTA) and global regulatory dossiers (CTD) for market authorization track record of successful interactions with worldwide regulatory agencies (new drug applications, pre-approval inspections) * Proficient in CMO screening and selection, contract negotiation, and managing development (formulation, process, analytical) and manufacturing (GMP) activities at CMOs, and preparing & managing budgets. Twenty-five years of experience in discovery support (lead optimization & candidate selection) preformulation characterization and formulation development for clinical trials of over 20 new drug candidates including development of enabling formulations as appropriate

Highlights:

• CMC
• Product Development
• Regulatory Affairs
• Good Manufacturing Practices
• Management
• Project Management
• Technical Lead
• DP
• Product Development
• Supply Chain
• Technical Operations