QOS
June 2, 2020
The value of the QOS should be to point reviewers at the most important information to support the quality of the drug in the most transparent presentation possible.
Senior Biologics Manufacturing Consultant
Dave is a technical operation executive and consultant with a very diverse background in biopharmaceuticals. A change agent with proven ability to transform teams, design and construct manufacturing facilities, and lead product development from process development through commercialization. Over a 30-year career, Dave managed Chemistry, Manufacturing and Control (CMC) operations staff, engineers, and development scientists; ranging up to 55 employees.
His Consultant experience includes:
Dave began his career in manufacturing at GENENTECH and progressed to biological process R&D at Idec, Biomarin, and Optimer Pharmaceuticals. Dave joined DSI in 2020 from Vaxart as an expert biologics consultant whose career focus has evolved toward applying principles of quality risk assessment and sound science to provide CMC guidance to all aspects of biological process drug development. Dave holds a B.S. in Biochemistry Magna Cum Laude from San Francisco State University.
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Head of Project Management
With over 35 years of industry experience, Tom brings a well-rounded and diverse background in biotech, pharmaceutical, medical device, and supply chain operations to our DSI Team. His extensive experience with both small start-up as well as mid to large sized companies provides him a firm understanding of a client’s needs as the relate to CMC Operations. Having an in depth understanding of a broad range of products ranging from bulk biologics through finished goods packaging enables Tom to best target a client’s needs and responsibilities for their products.
Tom brings a history of managing multiple facilities throughout his career while consistently reducing cost and maintaining outstanding compliance profiles and customer service. His collaborative leadership style, with an emphasis on creating long-term internal and external relationships with stakeholders, makes Tom an essential part of the DSI Leadership team.
Tom received his BS, Pharmacy from the Philadelphia College of Pharmacy and Science and his MBA in Operations Management from Drexel University
Senior Program Development Consultant
Judy Magruder has served as an advisor to emerging start-up and established pharmaceutical companies on development of in-line and pipeline products and opportunities with deep experience in key disciplines of drug development, facilitating effective program management to define, track, troubleshoot and meet business goals. Successfully developed small molecules, biologics, drug-device combinations, oral dosage forms, injectables, implants, transdermal and microneedle patches and a track record of building successful cross-functional teams especially at early stage innovators and significantly impacting achievement of project goals.
Judy received an MBA from Santa Clara University and a BS in Animal Science from the University of California Davis. Prior to joining DSI, Judy was an Independent Consultant and has held noteworthy roles in Program management and operations on the west coast at Zosano Pharma, Signature Therapeutics, DURECT Corporation and ALZA Corporation.