Director Early Phase Process Chemistry SMDD

Role: Lead synthetic molecule route commercialization and process optimization for drug candidates supporting clinical trials and regulatory submissions. Responsibilities include designing and developing new synthetic routes using modern technologies, leading cross-disciplinary teams, overseeing scale-up and tech transfer activities, and applying advanced analytical and modeling platforms to accelerate development. Collaborate with internal functions (CMC, Regulatory, Manufacturing) and external partners to ensure robust, compliant processes. Qualifications: Ph.D. in organic chemistry or related field with 10+ years (or MS with 15+ years) pharmaceutical process development experience. Preferred skills include expertise in active ingredient development, chemical process scale-up, regulatory submission authoring, PAT, process modeling, and project management. Biopharma relevance: focus on small molecules, synthetic APIs, from mid-development to commercialization, with exposure to process transfer, regulatory interactions, and drug substance manufacturing. Work setup: location in Indianapolis, IN; travel 0-10%; potential chemical exposure. The role demands leadership, innovative thinking, external engagement, and a strong publication record.