Mike Stelmah

About Mike Stelmah

With over 15 years in the pharmaceutical and biotechnology sectors, I contributed to…

Experience

1. Vice President & Head - Manufacturing, Cmc, Regulatory & Qa Cqa (Multiple Roles)

   Cornerstone Pharmaceuticals

   Jan 2018 — Present

   Oncology-focused breakthrough therapy development pharmaceutical company, with phase I - phase clinical trials in PANC, AML, CS and other oncology indications. • Key member of the executive leadership team, reporting directly to the CEO • Lead establishment and execution of a holistic and risk-balanced strategy for Manufacturing, CMC, Regulatory, QA, CDMO partnership, and pharmaceutical collaborations – resulting in start and completing of multiple phase trials, and execution corporate exit strategy • Key executive member in completing due diligence and establishing multimillion-dollar partnership agreements with Ono Pharmaceuticals, CDMO partnerships, and product licensing • P&L responsibilities for multiple departments • Negotiate CDMO contracts, quality agreements, perform direct partner oversight and audits

Skills

• Ema
• Validation
• Commercialization
• Pharmaceutical Industry
• Biomedical Engineering
• Gmp
• Six Sigma
• Mba
• Irna
• U.s. Food and Drug Administration (Fda)
• Combination Products
• Medical Devices
• Pmi
• Stage Gate Process
• Stage-Gate
• Sdlc
• Engineering
• P&L Management
• Iso 13485
• Design for Manufacturing
• Testing
• Cmc
• Process Improvement
• Strategy
• V&V
• Product Development
• Innovation Development
• Fda
• Organizational Management
• Engineering Management
• Regulatory Affairs
• Strategic Planning
• P & L Oversight
• Project Management
• Lean Manufacturing
• Verification and Validation (V&V)
• Manufacturing
• Biotechnology
• Biologics