Associate Director, Biologics New Product Commercialization

Role: Associate Director, Biologics New Product Commercialization, focused on transferring veterinary monoclonal antibody (mAb) products from R&D into commercial manufacturing. Responsibilities: lead cross-functional teams to ensure timely, right-first-time technology transfers to internal and external sites; manage project timelines, budgets, risks, and escalation; oversee process development, validation, and regulatory filing support; communicate progress and risks to senior stakeholders; drive best practices within the process transfer lifecycle. Requirements: Bachelor's in Chemical Engineering, Biotechnology, Biochemistry, or related; minimum 8 years post-graduate experience, including 4+ years in project leadership within regulated biopharmaceuticals, with at least 2 years involving external manufacturing (CDMOs). Expertise in technology transfer, process validation, risk assessments, and regulatory compliance (EMA, FDA, USDA) is essential. Preferred: deep knowledge of mAb manufacturing processes, regulatory experience, and familiarity with biopharma business processes. Skills: external manufacturing, project management, technical operations, strategic planning, and technical support. HighValue: monoclonal antibody biologics, veterinary drug development, process transfer, regulated environment (EMA/FDA/USDA), global coordination, and cross-site collaboration. Location options include Boxmeer (NL), Millsboro (DE), or DeSoto (KS); travel approximately 10%. The role is an individual contributor with matrix leadership in a global biopharma setting.