cmc scientist.

Process & Assay Development: Lead and manage integrated plans for process, formulation, and
analytical development, as well as GMP clinical testing and manufacturing activities at external
laboratories and CDMOs.
• Technology Transfer & Scale-Up: Oversee the transfer, qualification, and validation of analytical
methods, troubleshooting, and scale-up of manufacturing processes.
• Manufacturing Oversight: Supervise engineering runs, GMP drug manufacturing, labeling, and
packaging activities at CDMOs from Phase I through commercialization.
• Documentation & Compliance: Review batch records (DS, DP, L&P), author technical memos,
and manage manufacturing investigations (deviations, CAPA). Author and review CMC sections
for regulatory filings, development reports, and process development records.
• Cross-Functional Collaboration: Actively communicate and collaborate with other functional
areas to address challenges and achieve project goals.
• Additional Duties: Perform other duties as required to support the evolving needs of the
company.