Mike Cooper
A biopharmaceutical industry professional with over 20 years of experience in completing projects against timelines and budgets, cross-functional... | United States
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Mike Cooper’s Emails mh****@bm****.com
Mike Cooper’s Phone Numbers No phone number available.
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Mike Cooper’s Location United States
Mike Cooper’s Expertise A biopharmaceutical industry professional with over 20 years of experience in completing projects against timelines and budgets, cross-functional collaboration, and leading teams. Expertise in (1.) Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC) submissions for biologic and small molecule products; (2.) Pre-NDA gap assessment reviews; (3.) GMP inspections for biologics & vaccines; (4.) QA lot release of drug substance and drug product; (5.) Deviation and CAPA resolution; (6.) Facilities, utilities, and equipment validation. Experienced in the therapeutic areas of enzyme replacement therapies, multiple sclerosis, and oncology.
Mike Cooper’s Current Industry Nda
Mike
Cooper’s Prior Industry
Pharmatech Associates
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Chiron
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Novartis
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Bayer Healthcare
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Biomarin Pharmaceutical
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Nda
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Work Experience
Nda
Senior Consultant
Sat Apr 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Pharmatech Associates
Associate Director (Clinical and Regulatory Affairs)
Sun Dec 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Feb 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Biomarin Pharmaceutical
Senior Manager (Regulatory Affairs CMC)
Tue Jan 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jun 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Bayer Healthcare
Senior Manager (QA Finished Product Release)
Fri Jan 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Jan 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time)
Novartis
Associate Manager (QA Bulk Intermediate Release)
Mon Jan 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jan 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time)
Chiron
Specialist II (QA Commercial Product Release)
Sat Jan 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jan 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time)
Pharmatech Associates
Manager (Validation Services)
Fri Jan 01 1999 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jan 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time)Skills
Languages
Mike Cooper Email Addresses
FAQ About Mike Cooper
-
Mike Cooper is located at
United States -
Mike Cooper is a
A biopharmaceutical industry professional with over 20 years of experience in completing projects against timelines and budgets, cross-functional collaboration, and leading teams. Expertise in (1.) Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC) submissions for biologic and small molecule products; (2.) Pre-NDA gap assessment reviews; (3.) GMP inspections for biologics & vaccines; (4.) QA lot release of drug substance and drug product; (5.) Deviation and CAPA resolution; (6.) Facilities, utilities, and equipment validation. Experienced in the therapeutic areas of enzyme replacement therapies, multiple sclerosis, and oncology. Nda -
Mike Cooper currently works in the
Nda -
Mike Cooper specializes in
A biopharmaceutical industry professional with over 20 years of experience in completing projects against timelines and budgets, cross-functional collaboration, and leading teams. Expertise in (1.) Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC) submissions for biologic and small molecule products; (2.) Pre-NDA gap assessment reviews; (3.) GMP inspections for biologics & vaccines; (4.) QA lot release of drug substance and drug product; (5.) Deviation and CAPA resolution; (6.) Facilities, utilities, and equipment validation. Experienced in the therapeutic areas of enzyme replacement therapies, multiple sclerosis, and oncology. -
Mike Cooper speaks the following languages:
No languages available. -
Mike Cooper has prior experience in the following industries:
Pharmatech Associates , Biomarin Pharmaceutical , Bayer Healthcare , Novartis , Chiron , Pharmatech Associates -
Mike Cooper has the following professional experience:
Nda , Pharmatech Associates , Biomarin Pharmaceutical , Bayer Healthcare , Novartis , Chiron , Pharmatech Associates . -
You can view Mike Cooper’s
LinkedIn profile at LinkedIn URL. -
Mike Cooper’s work email addresses are
[email protected] . -
Mike Cooper works at
Nda
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