Debra McMichael
Associate Director, Analytical and Quality Control at Odonate Therapeutics™- Claim this Profile
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Bio
Experience
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Odonate Therapeutics™
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Associate Director, Analytical and Quality Control
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Feb 2020 - Present
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Pharmaceutical Consultant
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2018 - Present
Independent professional providing contract services, specializing in quality and compliance
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Horizon
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Ireland
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Biotechnology Research
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700 & Above Employee
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Sr. Manager, Quality
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2017 - 2018
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Sr. Manager, Quality Control, Stability
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2016 - 2017
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Manager, Quality Control, Stability
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2014 - 2016
Management and oversight of stability functions and reference standards at contract labs.
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Valeant Pharmaceuticals
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Stability Team Leader, Scientist 1
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2007 - 2014
Directed a team of four in cGMP stability operations (clinical phase to phase 4), for a contract drug development and consulting company, specializing in dermatological, ophthalmic, and topical products. Led stability protocol development, sample storage, environmental monitoring, internal and external test coordination, stability table design, and data compilation.
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Sr. QC Chemist
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1996 - 2007
Directed team of four Chemists over three shifts performing testing and release functions for aseptic manufacturing of commercial and NDA unit dose inhalation product solutions, including raw material, in-process, and final drug product analytical testing. Strategically prioritized lab activities and test scheduling, and conducted quality review of data.
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Education
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University of California, Davis
Bachelor's degree from UC Davis, Chemistry -
Casa Grande High School