Job Description
Description
Small Molecule Formulation and Process Development (FPD) provides formulation, process, and manufacturing support and technical expertise throughout research and development, from pre-exploratory to commercialization. A Scientist within FPD may support teams conducting compound screening to enable drug candidate selection, drug substance physio/chemical property assessment and form selection, development of clinical formulations and manufacturing processes, small molecule drug product manufacturing tech transfer and scale-up at internal and external sites, oversight of small molecule drug product manufacturing, and establishment a robust DP formulation and optimized manufacturing process to enable commercial production. FPD scientists develop the small molecule formulation and manufacturing process control strategies and authors technical reports, risk assessments, and regulatory filings from IND to NDA. FPD supports DP manufacturing process va...