Director/Senior Director, CMC Drug Substance Development

Role: Senior/Director-level CMC Drug Substance Development leader responsible for designing, executing, and overseeing chemical process development for biopharma drug candidates, with a focus on small molecules for virology and immunology. Responsibilities: lead drug substance strategy aligned with clinical and commercial goals; develop scalable synthetic processes for GLP toxicology, clinical supplies, and potential commercialization; manage a team of chemists; select and oversee external partners for process research, GMP production, and tech transfer; collaborate with cross-functional teams including Regulatory Affairs, Quality, and Non-Clinical Development; author and review regulatory documentation, including INDs and IMPDs. Requirements: PhD in chemistry or related field; 10+ years of drug substance process development and manufacturing experience; proven leadership managing projects and teams; extensive expertise in scale-up from lab to pilot and commercial plants; strong knowledge of GMP, safety protocols, and global partner management; experience writing and reviewing regulatory documents; familiarity with radiolabeled synthesis advantageous. Preferred: experience with Quality by Design, CDMO oversight, and global process development. High-Value: focus on small molecule drug development for virology/immunology, regulatory submission experience, and cross-functional leadership. Work setup involves approximately 10-20% travel; based in a collaborative, fast-paced environment emphasizing innovation, quality, and patient impact.