Associate Director, Drug Substance Tech Transfer Lead

About the role

AstraZeneca is building its first biologics manufacturing campus in Singapore, a USD 1.5 billion investment covering ADC, small-molecule API, large-molecule monoclonal antibody, conjugation, fill-and-finish and secondary packaging, with digital and automation infrastructure. This Associate Director role leads complex biologics drug substance technology transfers that safeguard reliable supply, covering transfers of approved biologics and ADCs and preparing new products for scale-up. You will work across Global CMC, manufacturing sites, quality, regulatory and external partners, driving strategy, execution and digital ways of working.

Key responsibilities

• Lead end-to-end drug substance tech transfer across internal and external sites, with a focus on post-approval biologics and ADCs, from planning through handover to commercial operations.
• Represent manufacturing operations in cross-functional planning so processes are scalable, transferable, inspection-ready and suitable for reliable commercial manufacturing.
• Use knowledge of upstream, downstream and conjugation to shape transfer strategy, assess sites and capabilities, and resolve issues across biologic modalities.
• Embed practical manufacturing considerations into transfer plans and decision-making with Global CMC and stakeholders.
• Partner with Manufacturing, MS&T, Quality, Regulatory, Supply Chain, Engineering and external partners to deliver transfer plans aligned to business priorities.
• Ensure GMP alignment, inspection readiness and robust technical documentation.
• Drive proactive risk management, standardization of transfer practices, and adoption of digital tools and data-led approaches.

Required profile

• Significant experience in CMC, drug substance production, MSAT or related biologics technical operations roles.
• Experience leading or supporting post-approval drug substance tech transfers, ideally including ADCs, and NPI transfers with a strong operations perspective.
• Bachelor's, Master's or PhD in Biochemical Engineering, Chemical Engineering, Biotechnology, Biology, Pharmaceutical Sciences or a related field.
• Ability to influence across a matrix organization and strong leadership and communication skills.

Required skills

• Familiarity with upstream, downstream and conjugation processes and tech transfer knowledge (a plus).
• Understanding of GMP operations, quality systems and regulatory expectations for biologics drug substance manufacturing and transfer.
• Desirable: hands-on experience with digital tech transfer platforms, data governance and knowledge management tools, and proven delivery of lifecycle changes and post-approval variations.