Michael is a forward-thinking innovator who has held executive leadership positions in the biopharmaceutical industry for over 20 years. He is recognized for deploying transformative work practices, leading-edge technology platforms and leveraging a global network of pharmaceutical, academic, and venture capital partners to achieve operational excellence while ensuring future competitive sustainability.
Michael is experienced in all stages of drug development including API and Drug Product research and development, site-to-site technology transfers, Regulatory CMC, Business Development, and Supply Chain. His expertise as a change agent, innovative strategist and international public speaker has……………
EXPERTISE
API & Drug Product Research & Development
Organizational Restructuring
Innovative Development & Manufacturing Facility Design and Implementation
Strategic New Technology Landscaping & Implementation
Leveraging Multi-Party Collaborations
EXPERIENCE
NextGenTech Pharma Consulting – CEO
Pfizer Pharmaceutical Sciences Technology & Innovation – Vice President
Sanofi-Aventis
Hercules Inc
EDUCATION
PhD, Case Western Reserve University
BA, Ohio Wesleyan University
ADDITIONAL
>55 publications, presentations and patents
Awarded ‘2017 Outstanding Alumnus of Chemistry’ from Case Western Reserve University
Served 2 years as Chairman of the Philadelphia Organic Chemistry Club (POCC)
Elected member of PhRMA API Technical Group (2006 – 2011)
Chairperson for ISPE Active Pharmaceutical Ingredients (API) CoP
HIGHLIGHTS
- Conceived and spearheaded a program to design, fabricate and implement a modular, continuous drug product OSD manufacturing facility that was assembled in a warehouse, is transportable and currently produces drug product supplies for an FDA approved oncology drug. The miniature factory, referred to as PCMM won the 2016 ISPE Facility of The Year Award.
- Oversaw cGMP Kg-laboratories, Pilot Plant, API external supply group, EH&S team, and Synthesis R&D groups as the acting head of a 200+ person large Pharma Chemical Development organization
- A highly successful agent for strategic change supporting future business needs who understands the power of well thought out business cases and stakeholder alignment processes to secure senior management support
- Utilization of internal/external collaborative business models enabled critical analytical, drug substance and drug product platform technologies to be developed and selectively implemented into CMC operations