Mike Radomsky

About Mike Radomsky

Technical, Development, and Business expert in pharmaceutical Chemistry, Manufacturing, and Controls (CMC) with 30 years experience in product development and commercialization of a wide range of therapeutic areas and dosage forms. • Led world-class cross-functional CMC and project teams. • A strong history of development of pipeline products from pre-IND through NDA/CTD and approval.• Specific technical expertise in formulation and drug delivery, drug product manufacturing, stability, cGMPs, and the development and manufacturing of a wide range of pharmaceutical and biotechnology products.• Experience in large corporations, established mid-size companies, start-ups, and emerging companies.• Broad based knowledge of the FDA regulations of pharmaceutical products and have represented my employers and clients with regulatory bodies by written communications, teleconferences, and in-person meetings• Responsible for the preparation, review, and editing of a range of regulatory documents including INDs, NDA/CTDs, Annual Reports, and Field Alerts.• Extensive experience in utilizing outsourcing (CMO/CROs) for product development and manufacturing.• Skilled in leading cross-functional teams in a variety of drug development and commercialization tasks.• Key contributor and inventor to the discovery and development of intellectual property.• Experience with legal, finance, business, and technical representatives to execute and manage supply agreements.Specialties: Pharmaceutical and Biotechnical Chemistry, Manufacturing and Controls: formulation development, process development, drug delivery systems, pharmaceutics/pharmaceutical sciences, sterile product manufacturing, stability studies and analysis, supply agreement execution and management, development of intellectual property, current Good Manufacturing Practices (cGMPs), dosage form development, outsourcing to CMOs and CROs, cross functional leader.

Experience

1. President

   Cmc Pharmaceuticals, Inc

   Jan 2015 — Present · Cleveland/Akron, OH, US

   CMC Pharmaceuticals provides drug product consulting and lab services for the development of a wide variety of pharmaceutical products. We provide pre-formulation, formulation, stability, analytical development, and cGMP lab testing services for products at preclinical, clinical, and commercial stages. We were established in 2014 and currently have two locations in Cleveland and Solon, Ohio.

Education

• The Johns Hopkins University

  Ph.D., Chemical Engineering

  1987 — 1991

• Rose-Hulman Institute of Technology

  B.S., Chemical Engineering

  1983 — 1987

Skills

• Gmp
• Drug Delivery
• Formulation
• Process Simulation
• Pharmaceutical Industry
• Cross-Functional Team Leadership
• Fda
• Technology Transfer
• Pharmaceutics
• Commercialization
• R&D
• Drug Development
• Life Sciences
• Biotechnology
• Change Control
• V&V
• Validation
• Manufacturing
• Chemistry
• Ind
• Product Development
• Biopharmaceuticals
• CRO
• U.s. Food and Drug Administration (Fda)