Justin Chow
Director @Sumitomo Pharma America, Inc.
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WORK HISTORY
Director @Sumitomo Pharma America, Inc.
Commercial Analytical Lead for Orgovyx and Myfembree + Clinical Analytical Lead and Program Lead for Pediatric Program and Liposomal Program · Author the analytical sections of the IND, IMPD, NDA, MAA, CBE and EMA Type Variations + regulatory responses. · Manage various CXOs to support development, release, stability and method validation with 10+ external FTEs. · Manage 2 to 3 scientists/associates to independently support contract sites and collaborate across multiple functions within the organization. · Author and manage phase appropriate specifications from clinical to commercial. · Provide chromatography, mass spectrometry and other analytical area expertise for program development and technical challenges. · Ensure clinical trial materials are available and release testing completed on time · Review GMP methods, lab investigations, data interpretation, and trends. · Develop dissolution and related substance stability indicating methods, include multiple actives methods. Leadership & Operational Excellence · Author and implement GMP-compliant SOPs in collaboration with QA, strengthening regulatory adherence and operational consistency across analytical functions. · Financial planning and budgeting for the department by partnering with finance and senior leadership, ensuring alignment with corporate objectives and optimizing resource allocation. · Participate in cross-functional evaluations for in-licensing opportunities, contributing to strategic portfolio expansion and supporting business development initiatives. · Mentor and coach direct reports, fostering professional growth through tailored development plans, goal setting, and succession planning to build a high-performing team. · Champion process improvements and compliance initiatives, driving efficiency and maintaining audit readiness within a regulated environment.
EDUCATION
University of California, Davis
BS, Molecular & Cellular Biology
California State University-Sacramento
MS, Analytical Chemistry
ABOUT JUSTIN CHOW
CMC project lead, analytical chemist and supervisor with strong understanding of different stages of development from Phase 1 to Commercial. I have worked on 5+ NDAs with regulator filing experience for MAA and the rest of world. I’ve led teams of analytical scientists internally and externally. Together, we have been responsible for analytical chemistry support for all phases of clinical development for small molecule drug substances and drug products, including combination products with multiple actives. Furthermore, I have authored regulatory responses for NDA and MAA leading to drug product approvals. My strong technical skills are supported by 10+ years of hands-on experience in the laboratories, including HPLC, GC, mass spectrometry and dissolution development and troubleshooting skills. · Authored analytical sections of the NDA and MAA for 5+ programs and INDs and IMPDs.· CXO selection and management to perform release and stability of API and drug products.· Subject Matter Expert in HPLC and dissolution method development.· Analytical lead for late phase programs.· Managed and successfully closed numerous analytical investigations/deviations.· Extensive hands-on laboratory and method development experience.· Strong collaboration across all CMC and Quality functions
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