Michael O'Donoghue Email & Phone Number
Senior Director Vendor Management and Compliance @ Amici Pharmaceuticals
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Michael O'Donoghue Location
- Hudson, NH, US
Michael O'Donoghue Work
- 2026 -now Senior Director Vendor Management and Compliance @
- 2025 -2026 Director Vendor Management and Compliance @
- 2025 -2026 Director Vendor Management and Compliance @ Amici Pharma Inc.
- 2024 -2025 Vice President of Product Development and Production @
- 2024 -2025 Vice President of Product Development @
- 2023 -2024 Principal Consultant @ All Pharma Consulting
- 2023 -2024 Owner @ All Pharma Consulting LLC
- 2021 -2023 General Manager @
- 2021 -2023 General Manager @ SGS Quay Pharmaceuticals
- 2017 -2021 Senior Director of Operations @ CMIC CMO USA Corporation
- 2009 -2021 Director of Operations @ CMIC CMO USA Corporation
- 2009 -2021 Senior Director of Operations @ CMIC CMO USA Corporation
- 2004 -2009 Group Leader Oral Solids Operations @
- 2007 -2009 Group Leader @
- 2004 -2007 Process Development Scientist @
- 2002 -2004 Formulation Technical Services @
- 2002 -2004 Development Scientist @
- 2001 -2002 Equipment Expert @ Addecco
- 1999 -2001 Chemist @ lab Support
- 1995 -1999 Sales Representative @ Varian Inc,
- 1988 -1995 Scientist, and LIMS Manager @ Pharmakinetics
- 1986 -1988 Associate Biochemist @ Carter Wallace
- 1983 -1986 Forensic Toxicologist @ NJ Forensic Science Bureau
Michael O'Donoghue Education
- Upsala College
BS (Biochemistry)
1977-1982
Michael O'Donoghue Skills
- Manufacturing
- GMP
- Technology Transfer
- FDA
- Pharmaceutical Industry
- CAPA
- Validation
- Sop
- Change Control
- Contract Manufacturing
- Drug Development
- GLP
- 21 CFR Part 11
- Quality System
- Quality by Design
- Manufacturing Operations
- Formulation
- cGMP manufacturing
- Trackwise
- Product Development
- R&D
- Plant Management
- Plant Expansion
- Regulatory Affairs
- Biopharmaceuticals
- Biotechnology
- Regulatory Submissions
- Analytical Chemistry
- Team Building
- Quality Assurance
- Pharmaceutics
- Cleaning Validation
- V&V
- HPLC
- FDA GMP
- Clinical Development
- Regulatory Requirements
- CRO
- Computer System Validation
- LIMS
- Aseptic Processing
- GCP
- Commercialization
- ISO 13485
- Clinical Trials
- Lifesciences
- Vaccines
- GxP
- U.S. Food and Drug Administration (FDA)
- u.s. Food and Drug Administration Fda
- u.s. Food and Drug Administration
Michael O'Donoghue Summary
- Michael O'Donoghue, based in Hudson, NH, US, is currently a Senior Director Vendor Management and Compliance at Amici Pharmaceuticals. Michael O'Donoghue brings experience from previous roles at Amici Pharmaceuticals, Amici Pharma Inc. and Applied Biological Laboratories Inc.. Michael O'Donoghue holds a 1977 - 1982 BS in Biochemistry @ Upsala College. With a robust skill set that includes Manufacturing, GMP, Technology Transfer, FDA, Pharmaceutical Industry and more. Michael O'Donoghue has 3 emails and 3 mobile phone numbers on RocketReach.
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