Mike Stelmah

Vice President & Head - Manufacturing, CMC, Regulatory & QA/CQA (Multiple Roles) at Cornerstone Pharmaceuticals
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Contact Information
us****@****om
(386) 825-5501
Location
New York City Metropolitan Area

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Pat Eddy

Mike, managed new devices for Ohio Medical and provided key leadership for the success of these products through their creation and listing with the FDA. Mike is very detail orientated and provided guidance for the entire organization for regulated devices for Ohio Medical Corporation.

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Credentials

  • Leadership Development Program - LDP
    Center for Creative Leadership
    Aug, 2021
    - Sep, 2024
  • RAC-Global
    Regulatory Affairs Certification Program
    Jun, 2016
    - Sep, 2024
  • RAC-US
    Regulatory Affairs Certification Program
    Jun, 2016
    - Sep, 2024
  • - Negotiation and Leadership
    Harvard Law School
  • - Problem Solving and Decision Making
    Kepner-Tregoe
  • - Six Sigma Black Belt
    ADMD
  • ABC of Management
    REGENERON PHARMACEUTICALS / CHANGE RESULTS CONSULTING
  • FDA Medical Device Pre-Submission Program and FDA Meetings
    International Pharmaceutical Academy
  • FIOLAX ACADEMY - Tubing Glass, Drug Container Interactions, Glass Defects
    SCHOTT
  • Good Clinical Practices
    Barnett International
  • Lead Auditor Training for ISO 13485
    Oriel STAT A MATRIX
  • Project Management Professional (PMP)
    Project Management Institute
  • Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals (Dual)
    Regulatory Affairs Professionals Society (RAPS)
  • Risk Management and Analysis for Medical Devices
    Oriel STAT A MATRIX

Experience

  • Cornerstone Pharmaceuticals
    • United States
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Vice President & Head - Manufacturing, CMC, Regulatory & QA/CQA (Multiple Roles)
      • 2018 - Present

      Oncology-focused breakthrough therapy development pharmaceutical company, with phase I - phase III 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 III 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 Show less

  • Legendary Solutions, LLC
    • United States
    • Pharmaceutical Manufacturing
    • CEO and Founder
      • 2015 - Present

      Pharmaceutical, Biotechnology, Medical Device consulting focused on CMC, Regulatory, and Strategy Pharmaceutical, Biotechnology, Medical Device consulting focused on CMC, Regulatory, and Strategy

  • Act Forward Inc.
    • United Kingdom
    • Truck Transportation
    • 1 - 100 Employee
    • Chairman Of The Board Of Directors
      • Jan 2016 - Jun 2023

      Led the board of Act Forward Inc to further their philanthropic mission. Led the board of Act Forward Inc to further their philanthropic mission.

  • Alnylam Pharmaceuticals
    • United States
    • Biotechnology Research
    • 700 & Above Employee
    • Director, Regulatory Affairs CMC & Combination Products
      • 2017 - 2018

      Key member of executive leadership team and planning committee – developing regulatory, CMC, combination product and corporate strategy - executing and leading collaboration projects Key member of executive leadership team and planning committee – developing regulatory, CMC, combination product and corporate strategy - executing and leading collaboration projects

  • Regeneron Pharmaceuticals, Inc.
    • Head of Combination Products, Regulatory Affairs / Technical Operations (Multiple Roles)
      • 2012 - 2017

      • Responsible for all Regeneron combination product regulatory/development activities, the group leading these activities, and collaborating with alliance partners like Sanofi, Bayer, Teva, and Mitsubishi Tanabe Pharma • Proposed, developed and executed global submission/approval strategy, development and manufacturing plans with direct presenting and approval from CEO, site heads, and collaboration partners • Responsible for all Regeneron combination product regulatory/development activities, the group leading these activities, and collaborating with alliance partners like Sanofi, Bayer, Teva, and Mitsubishi Tanabe Pharma • Proposed, developed and executed global submission/approval strategy, development and manufacturing plans with direct presenting and approval from CEO, site heads, and collaboration partners

  • Ohio Medical Corporation
    • United Kingdom
    • Health, Wellness & Fitness
    • Engineering Manager/Project Engineer
      • 2011 - 2012
  • Inter-Med / Vistal Dental Products
    • United States
    • Medical Equipment Manufacturing
    • Product Development Project Manager
      • 2011 - 2011
  • ZOLL Medical Corporation
    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Design Engineer
      • 2008 - 2010
  • University of Illinois at Chicago
    • United States
    • Higher Education
    • 1 - 100 Employee
    • Research Assistant, Design Engineer, Safety Technician
      • 2004 - 2008
  • Lingvobit
    • United States
    • Marketing Specialist
      • 2000 - 2004

Education

  • University of Illinois Chicago
    MBA, Management and International Business
    2009 - 2010
  • University of Illinois Chicago
    B.S., BioEngineering
    2004 - 2009
  • Columbia University in the City of New York
    N/A, Industrial Engineering - Systems Engineering

Community

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