Senior Manager, CMC Process Development

Lead strategy and execution of raw material manufacturing, regulatory classification, and supply for oligonucleotide programs on the Late Phase Development team. Define and defend regulatory starting material designations for synthetic routes in collaboration with Regulatory Affairs, authoring and reviewing RSM justification sections for regulatory filings. Provide technical oversight of small molecule synthesis, impurity control strategies, and process chemistry while assessing raw material specifications to ensure fitness for intended use. Manage day-to-day relationships with CMOs and suppliers as the primary technical point of contact, leading supplier selection onboarding and supporting technology transfer to kilo-scale manufacturing. Direct PD scientists, prioritize workflows, and prepare technical reports, SOPs, and Work Instructions to meet project deliverables.