VP, Technical Operations

Role: Vice President of Technical Operations at Akebia, overseeing end-to-end CMC strategy for small-molecule therapeutics from candidate selection through lifecycle management. Responsibilities: lead and develop the CMC organization, define phase-appropriate strategies covering drug substance and drug product development, validation, technology transfer, and manufacturing; oversee external manufacturing partners; ensure compliance with regulatory standards; manage resources, budgets, and cross-functional collaboration with Supply Chain, Regulatory Affairs, and Quality teams; represent Technical Operations in executive and portfolio planning. Requirements: MS/Ph.D. in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, or related field; extensive experience in small-molecule drug development, formulation, process validation, technology transfer, and commercial manufacturing; proven leadership in managing external partners and multidisciplinary teams; deep knowledge of cGMP, FDA, ICH, and global regulations; experience supporting INDs, NDAs, and lifecycle changes. HighValue: small-molecule drug development, formulation (oral solid and liquid), process validation, commercialization, lifecycle management, global manufacturing, regulatory compliance, cGMP. WorkSetup: based in Cambridge, MA with transition to Waltham, MA; flexible hybrid work model.