DAN TOROK

Dan Torok
Director, API Manufacturing and Process Development

Dan is a seasoned synthetic organic chemist whose education includes a BS from Bowling Green State University, MS from the University of Arizona and a PhD in Synthetic Organic Chemistry from the University of Iowa as well as a NIH postdoctoral fellowship in microbiology and medicinal chemistry. Daniel has over 15 years of experience in process development, scale up, optimization and the manufacturing of products, including intermediates, APIs, highly active APIs, and injectable grade APIs. He is highly proficient and well-versed in global technology transfers to internal and external cGMP manufacturers for the scale up and commercialization of APIs. His work experience includes preparing and contributing to the preparation and submission of CMC portions of DMFs, as well as work involving all QA aspects of API manufacturing and development. Daniel is also well versed in Project/Product Management in the API industry, including customer relations, production, shipment, scheduling and logistics, sourcing, and purchasing. Dan has held positions of increasing responsibility at American Cyanamid, Lonza and Hovione.

His accomplishments include:

• Management of product portfolios worth over $1 Billion in yearly sales including P&L responsibility, budgeting and long term stability.
• Project management of the first injectable grade API manufactured within a newly built CRO facility as well as the introduction of the first multistep highly unstable API process into the same facility.
• Extensive hands-on experience with technology transfer and development of data packages required for the cGMP validation of multistep processes on commercial scale (QBD and DOE).
• Strong aptitude for customer relations.
• Strong working knowledge of cGMPs, process control, quality management systems.

Thorough understanding of synthetic organic chemistry and chemical process development, including solid state polymorphism issues, as well as experience in particle design.

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