Executive Director, Process Engineering

Overview In this role you will lead the cell therapy process engineering function, shaping scalable manufacturing processes from development through commercialization. You will build and guide a multi-site team, drive global technical standards, and ensure compliant, cost-effective production. The role sits at the intersection of R&D, Manufacturing and Regulatory Affairs to advance AstraZeneca’s cell therapy pipeline. You will lead digital initiatives and strategic make-vs-buy decisions to accelerate delivery of therapies. Compensation / Benefitscompetitive base salaryhybrid in-person work (minimum three days in office)opportunity to lead multi-site global programlocation flexibility (Gaithersburg MD or Santa Monica CA)vaccination policy with accommodationsambitious mission to bring medicines to patients ResponsibilitiesLead the Late-Stage Process Development function for Cell Therapies across multiple sitesCreate and deploy global technical standards for cell therapy (validation, sterility, raw materials, single-use tech, packaging) within quality systemsDesign and oversee process validation, qualification and monitoring strategies with master validation plansBuild and manage a multi-site organization to support the product portfolio and knowledge exchangeOversee resource allocation and strategic make-vs-buy decisions per project priorities and tech strategiesDrive innovation by integrating internal and external expertise and leading digital programs aligned with CTO CGTEnsure compliance with regulations (GxP, GMP, HSE) and manage regulatory submissionsProvide technical leadership for new or improved cell therapy production processesAuthor/regulatory review of CMC packages for IND, BLA/MAA/NDAAddress health authority inquiries during filings and approvalsOversee process development, qualification, and transfer from PD to Operations for GMP manufacturingFulfil post-approval commitments for commercial products Key requirementsPh.D. in Chemical Engineering, Bioengineering, Biotechnology, or related field (or Master’s with relevant experience)10+ years in process engineering with >=10 years in leadership in biotech/pharmaExperience in cell therapy or biologics manufacturing (design, scale-up, optimization)Strong knowledge of GxP and data integrityProven track record leading a large team (30+ members) with CAR-T/human stem cell therapies and related processesleadership and team managementcross-functional collaborationstrategic thinkingcell therapy manufacturingprocess design and scale-upprocess validation and transfer