Senior Director, Manufacturing Science and Technology, Cell Therapy Technical Operations

AstraZeneca is seeking a Senior Director of Manufacturing Science and Technology (MSAT) to serve as senior-technical leader for the end-to-end Cell Therapy manufacturing across a global network of AstraZeneca’s manufacturing sites. You will be responsible for the technical oversight of cell therapy manufacturing processes from at-scale process validation through commercialization and life cycle management of cell therapy products manufactured at internal and external sites.

This is a leadership position responsible for developing and managing a team.

Your group will own the cell therapy manufacturing lifecycle from tech transfer of the pivotal manufacturing process to the process validation, commercialization, and post-approval process improvements partnering with

Late-stage

Process Development,site Manufacturing Science and Technology, and Manufacturing Operation steams.

• Define and execute the Global MSAT function strategy aligned with Cell Therapy Technical Operations to enable development and supply objectives across clinical and commercial stages.

• Build, mentor, and develop a high-performing Global MSAT team with deep expertise in cell therapy technical development and operations.

• Serve as a core member of the CMC lifecycle management team, contributing to long-range supply planning, risk mitigation, and operational excellence.

• Develop technical standards and templates for the process validation and market approval workflow including, authoring of validation master plan, validation protocols, validation and manufacturing campaign summary reports.

• Represent Global MSAT in the technology transfer and process characterization teams to ensure successful commercialization of cell therapy products

• Represent Manufacturing Operations in the CMC team, ensuring high-quality and timely program deliverables (clinical & commercial supply, site approvals)

• Develop PPQ readiness and PPQ execution technical framework for the site MSAT team and oversee execution at the manufacturing sites

• Develop and implement Proactive Process Analysis (PPA) and Continued Process Verification (CPV) strategies across manufacturing sites to ensure continued process understanding and process control across all manufacturing sites

• Provide technical oversight across cell therapy manufacturing lifecycle — from pivotal manufacturing readiness to commercial and post-approval.

• Develop and manage post-approval process optimization initiatives, comparability strategies, ensuring scientific rigor and managing regulatory risks.

• Identify and implement process improvements that improve process robustness, cost of goods, plant throughput, and supply continuity.

• Proactively identify and mitigate technical and operational risks; drive lessons-learned cycles and standardization across sites and teams.

• Serve as the senior accountable MSAT leader for regulatory submissions — Pivotal INDa, BLA, MAA, and supplements — authoring and approving CMC sections with high efficiency and optimal content.

• Lead MSAT preparedness and technical support for health authority inspections and audits.

• Partner with quality and regulatory to maintain full compliance with cGMP, ICH guidelines, and global regulatory expectations.

• Develop and defend sound scientific justifications for the integrated control strategy, and lifecycle changes.

• Lead global Change Controls and ensure timely implementation and compliance working with site MSAT team

You will work in close partnership with:

• Quality — ensuring process compliance and product quality standards

• CMC Regulatory — aligning on submission strategy and regulatory…