Sr. Director Drug Product Development and Manufacturing

Role: Lead drug product development for small-molecule programs, focusing on formulation, manufacturing process development, and regulatory compliance. Responsibilities: establish scalable formulations, oversee technical activities at CMOs—including tech transfer, process validation, and clinical supply—coordinate with Quality and Analytical teams, author regulatory submissions (INDs, NDA/MAA), and manage internal teams. Qualifications: Ph.D. in Chemistry, Pharmaceutical Sciences, or related field with 10+ years of late-phase drug product experience, particularly in GMP oral solid dose manufacturing, formulation development, and CMO management. Extensive knowledge of cGMP, ICH, FDA, EMA, and global packaging regulations is essential. Preferred: strong leadership skills, cross-functional collaboration, excellent communication, and the ability to manage complex projects in a fast-paced environment. High-value: focus on small-molecule formulations, late-phase development, regulatory filings, and global manufacturing compliance. Work setup: not specified; travel up to 25% domestically and internationally.