Principal Scientist/Associate Director, Process Chemistry

The opportunity: As Principal Scientist/Associate Director, Process Chemistry, you'll have primary oversight of drug substance process development for your assigned programs. Working in close partnership with Medicinal Chemistry, you'll set the process development strategy from early route design through clinical supply and lead its execution through a network of external CDMO partners. You'll represent Process Chemistry on cross-functional program teams alongside CMC, Regulatory, Quality, and Clinical Supply, as Odyssey's pipeline advances from preclinical into clinical development. Your primary objectives will be: Hold primary oversight and accountability for drug substance process development on assigned programs, serving as the Process Chemistry lead and drug substance representative on cross-functional program and CMC teams Set process development strategy in collaboration with Medicinal Chemistry, providing early input on route selection, scalability, cost of goods, and developability during lead optimization and candidate selection, and ensuring a smooth transition of chemistry from discovery to development Define phase-appropriate drug substance development plans from preclinical through clinical stages, including route selection, regulatory starting material strategy, impurity control, and specification and control strategy Direct the design, development, and scale-up of safe, robust, phase-appropriate synthetic processes that meet program goals for timeline, quality, and cost Select, manage, and hold accountable external CDMO partners; set technical direction, review and approve workplans, data, and batch records, and drive resolution of technical and supply issues Own drug substance objectives, timelines, milestones, and budgets for assigned programs; contribute to annual planning, resource forecasting, and contract negotiations with Finance and Legal Anticipate technical and supply risks and develop mitigation, backup, and contingency plans to ensure uninterrupted drug substance supply Partner with CMC, Analytical, Formulation, Quality, Regulatory, Legal/IP, Finance, and Clinical groups to integrate drug substance plans into overall program and CMC strategy Lead or oversee API solid form (salt and polymorph) screening and selection in support of pharmaceutical development Author and review drug substance sections of CMC regulatory filings (IND, IMPD, and later-phase submissions) and represent drug substance in health authority interactions as needed Communicate program status, risks, and recommendations to senior leadership and governance committees Mentor and develop scientists, with potential for direct reports; contribute to building Process Chemistry capabilities, best practices, and the external CDMO network Evaluate and champion new technologies (e.g., flow chemistry, biocatalysis, process analytical technology) where they add value to programs