Senior Manager, Process Development

Role: Senior Manager, CMC Process Development leading late-phase oligonucleotide therapeutic programs, focusing on raw material manufacturing, regulatory classification, and supply chain management. Responsibilities: define and defend RSM strategies aligned with ICH Q11, author regulatory documentation (IND/IMPD, NDA, MAA), oversee synthetic route evaluations, assess raw material specifications, support technology transfer, manage relationships with CMOs and raw material suppliers, lead vendor selection, and supervise process development scientists. Collaboration involves cross-functional teams including Regulatory, QA, Discovery, and Manufacturing. Requirements: Ph.D. in Organic Chemistry or related with 5+ years, M.S. with 10+ years, or B.S. with 12+ years of industry experience in chemistry; expertise in pharmaceutical drug substance development and process chemistry. Preferred: advanced degrees, experience with CMC regulatory interactions, GMP compliance knowledge, prior team leadership. HighValue: experience with RNAi biologics, late-stage process development, regulatory filings, small molecule synthesis oversight, and vendor management. WorkSetup: onsite in Verona, WI; no travel specified.