Associate Director, Drug Substance Tech Transfer Lead, Global Tech Operations

About the role

AstraZeneca is looking for an Associate Director, Drug Substance Tech Transfer Lead within Global Tech Operations (GTO). The role provides technical and operational leadership for drug substance technology transfers across the biologics portfolio, focusing mainly on post-approval transfers including ADCs, while supporting NPI transfers by representing Operations requirements and enabling scalable, robust and reliable commercial manufacturing across internal and external networks.

Key responsibilities

• Lead end-to-end post-approval drug substance technology transfers across internal and external sites, from strategy and planning through execution, qualification and handover to commercial operations.
• Support NPI transfers by representing the Operations perspective and ensuring processes are scalable and suitable for routine commercial manufacturing.
• Apply upstream, downstream and conjugation expertise to define transfer strategies, assess site readiness and resolve issues across diverse biologic modalities.
• Assess site capability and readiness, including technical fit, equipment and facility suitability, capacity, operational maturity, compliance and lifecycle requirements.
• Develop integrated transfer plans with Manufacturing, MS&T, Quality, Regulatory, Supply Chain, Engineering, Global CMC and external partners.
• Embed GMP, inspection readiness, knowledge management and complete technical documentation throughout transfer planning and execution.
• Lead identification, mitigation, escalation and resolution of process, equipment, site, quality, compliance, timeline and supply risks.
• Drive standardization, simplification and digital technology transfer approaches to improve data quality, governance, knowledge transfer and execution efficiency.

Required profile

• Technically credible and operationally minded leader with significant experience in CMC, drug substance manufacturing, MS&T or related biologics technical operations roles.
• Solid understanding of upstream, downstream and conjugation processes; technology transfer experience is a plus.
• Experience supporting biologics portfolios with diverse modalities, and ideally post-approval and NPI drug substance tech transfers, including ADCs.
• Bachelor's, Master's or PhD in Biochemical Engineering, Chemical Engineering, Biotechnology, Biology, Pharmaceutical Sciences or a related field.
• Strong leadership, communication and problem-solving skills, able to influence across a matrix organization and collaborate with technical teams, operational partners and senior leaders.

Required skills

• Good understanding of GMP operations, quality systems and regulatory expectations for biologics drug substance manufacturing and transfer.
• Ability to assess internal and external manufacturing capabilities, site readiness and transfer risk.
• Interest in or experience using digital technology transfer to improve delivery.