Dr. Bratin is an innovative pharmaceutical scientist with considerable experience in the development, regulatory submission, approval, and commercialization of novel medicines. His background encompasses numerous technical, management, technology transfer, and matrix team leadership roles in Pfizer’s Analytical R&D, Regulatory CMC, Supply Chain, and Pharmaceutical Sciences Portfolio & Resource Operations departments. Throughout his career, Dr. Bratinl has been a sought-after expert in all aspects of CMC sciences, outsourcing, in-licensing, due diligence, integration of acquisition assets, project management and analytical-related technology development. His strong negotiating skills have enabled cost savings for clinical programs and shared technologies with Pfizer partners and collaborators, while his outstanding collaboration and networking skills have provided impactful results in relatively short timelines.
As Pharmaceutical Sciences Technical Team Leader at Pfizer, Dr. Bratin was responsible for technology development & transfer of API and drug product manufacturing processes, alongside the associated analytical controls of Pfizer’s commercial manufacturing division. Activities included developing the CMC regulatory strategy, and coordination of clinical supply manufacture & packaging timelines for ongoing clinical programs. He additionally represented Pharmaceutical Sciences teams in Pfizer’s global development groups and was a core member of a Pharmaceutical Sciences project team involved in development of a global resource and activity-based drug development model. As Pharmaceutical Sciences Portfolio Director of Pfizer Japan’s Development Research Organization, Dr. Bratin provided technical consultation to internal development teams regarding Japan CMC submission strategies. He additionally Identified and managed internal and external CMOs for novel products and led Pharmaceutical Science due-diligence evaluations of external drug candidates; provided analytical support for the development of new human (traditional and peptide/protein) and animal health pharmaceuticals; and evaluated and purchased new analytical technology, including robotics, NIR spectroscopy and high-performance liquid chromatography (HPLC), and oversaw the introductions of a chromatography/LIMS system. Dr. Bratin also developed the first automated fiber optic/robotic dissolution system for tablets and capsules, as well as a robotic fiber optic system for confirmation of potency and identity of packaged clinical supplies. He has assisted in the design of a novel primary packaging identification scheme for clinical supplies, which eliminated need for chemical testing of clinical study supplies.