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Brad Berkowicz
Takeda Pharmaceuticals Inc.
Director, US, Oncology & External Supply Small Molecule
Brad earned a BS in Chemical Engineering from Purdue University in 1993 and an MBA from Lehigh University in 1999. Brad began his professional career with Merck in various roles that focused on technology transfer, process validation, technical support, and compliance initiatives. During this time, Brad made significant contributions in the developing strategic validation guidance documents and training modules, and ensuring new products were successfully validated for launch.<br><br>
In 2001, Brad left Merck and joined Schering-Plough in Kenilworth, NJ. Over the next 8 years, Brad supported the development, technology transfer, validation, launch, and technical support for several solid dosage products. He was instrumental in developing Schering-Plough’s strategic approaches to process and packaging validation. He was also the technical leader in establishing and implementing best practices for assessing, defining, and validating manufacturing processes under the Consent
Decree, which were subsequently adapted for use in European manufacturing sites.<br><br>
In 2009, Brad transferred to Merck’s Pharmaceutical Commercialization Technology group and was responsible for the development, scale-up, validation, and commercialization of new drug products. He also led one of the teams responsible for revising Merck’s process validation guidelines to align with the updated FDA Guidance.<br><br>
In January 2013, Brad joined Shire and currently holds the position of Director in the Small Molecule Operating Unit's Drug Product Technical Services group. He is responsible for technical support, technology transfer, and validation activities for solid dosage products.
In 2001, Brad left Merck and joined Schering-Plough in Kenilworth, NJ. Over the next 8 years, Brad supported the development, technology transfer, validation, launch, and technical support for several solid dosage products. He was instrumental in developing Schering-Plough’s strategic approaches to process and packaging validation. He was also the technical leader in establishing and implementing best practices for assessing, defining, and validating manufacturing processes under the Consent
Decree, which were subsequently adapted for use in European manufacturing sites.<br><br>
In 2009, Brad transferred to Merck’s Pharmaceutical Commercialization Technology group and was responsible for the development, scale-up, validation, and commercialization of new drug products. He also led one of the teams responsible for revising Merck’s process validation guidelines to align with the updated FDA Guidance.<br><br>
In January 2013, Brad joined Shire and currently holds the position of Director in the Small Molecule Operating Unit's Drug Product Technical Services group. He is responsible for technical support, technology transfer, and validation activities for solid dosage products.
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