Benjamin S Isaacs
Lawrence,KS
Summary
Dynamic leader with a proven track record in CMC leadership at Formatech Inc., transforming a startup into a profitable CDMO. Expert in pharmaceutical development and cross-functional collaboration, driving innovative solutions and financial growth. Skilled in project planning and problem-solving, delivering high-quality products to a global client base.
Overview
30
30
years of professional experience
Work History
General Manager
Argenta Research, LLC
Lawrence, KS
07.2018 - 12.2023
- Business, Scientific and Innovative pharmaceutical development for veterinary products as Head of Pharmaceutical Sciences-US (a GM role) with focus on CMC for product registration.
- Brought a non-profitable Small Molecule product development business unit to profitability and revenue growth while expanding the team and infrastructure.
- Management (technical [dosage form development], fiscal and Health & Safety) of the Pharmaceutical Sciences Group in Kansas to drive Product Development, Analytical Sciences, Device and Drug Delivery.
- Compressed tablets, Oral liquids & chewable novel dosage forms.
- A business unit of Argenta, a CDMO headquartered in UK
Product Development Manager
Ology Bioservices
Alachua, FL
04.2013 - 09.2017
- Product development management that included CMC leadership of several cross-functional teams (internal, external and DOD & DHHS/BARDA) to drive products towards IND, BLA and ANDA.
- Managed Programs to address - FDA Critical Drug Shortages (MgSO4, Succinyl Choline Chloride, Nitroglycerin) with attendant product portfolio assessments.
- API (China and India) vendor selection and qualification.
- CMC documentation for regulatory submissions.
- DHHS/BARDA Program Management including budgets.
- Technology Transfer from R&D to cGMP manufacturing at a CMO including a pandemic FLU vaccines.
- Sterile Aseptic product, process & assay development & manufacture of anti-nerve gas agent(s) and auto-injector delivery systems.
- Previously, Nanotherapeutics, Inc., a CDMO for DHHS (BARDA) and DOD programs
CEO and President
Formatech Inc.
Andover, MA
10.1993 - 08.2012
- Built company with focus on CMC leadership turning a fledgling start up formulation development CRO (contract research organization) to a well-integrated and profitable CDMO (contract development and manufacturing organization) with a global client-base.
- Bio/Pharmaceutical Formulation & Dosage Form Development - Small Molecule & Biological and NCE Formulation and Dosage Form Development for IND, NDA and ANDA and BLAs.
- Innovative accomplishments include high concentration Monoclonal antibodies.
- Sterile Aseptic product and CMC process development including freeze-drying monoclonal antibodies, other biologicals, and new chemical entities.
- Biological process development for biopharmaceuticals.
- Pharmaceutical CGMP Aseptic Fill-Finish Manufacturing - Built, validated, and commissioned a CGMP sterile fill and finish plant in Andover, MA.
- Managed and grew this CGMP manufacturing operation to account for ~80% of total company annual revenues by serving a worldwide client base.
- A CDMO in Andover, MA
Education
Ph.D. - Chemistry
University of Oklahoma
Norman, OKSkills
- Contract development and manufacturing organizations (CDMO)
- CMC leadership
- Pharmaceutical development
- Product management
- Cross-functional collaboration
- Financial acumen
- Problem solving
- Project planning
Timeline
General Manager
Argenta Research, LLC
07.2018 - 12.2023
Product Development Manager
Ology Bioservices
04.2013 - 09.2017
CEO and President
Formatech Inc.
10.1993 - 08.2012
Ph.D. - Chemistry
University of Oklahoma