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

AstraZeneca • Gaithersburg, MD

8d • $216,996 - $325,494 • Hybrid

About The Position

AstraZeneca is seeking a Senior Director of Manufacturing Science and Technology (MSAT) to serve as a senior technical leader for end-to-end Cell Therapy manufacturing across a global network of AstraZeneca’s manufacturing sites. This role is 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 leadership position is responsible for developing and managing a team. The group will own the cell therapy manufacturing lifecycle from tech transfer of the pivotal manufacturing process to process validation, commercialization, and post-approval process improvements, partnering with Late-stage Process Development, site Manufacturing Science and Technology, and Manufacturing Operations teams.

Requirements

• B.S or M.S. or Ph.D. in Chemical/Biochemical/Biomedical Engineering, Bioengineering, Biochemistry, Biotechnology, Cell Biology, or a closely related discipline. Advanced degree preferred.
• 12+ years of progressive experience for cell therapy/biologics/vaccines modalities in technical development, manufacturing operation, CMC leadership or CMO management areas.
• Extensive background in GMP manufacturing operations, process validation, PPQ, CPV, and regulatory submission preparation.
• Proven record of building, leading, and mentoring high-performing technical and cross-functional teams.
• Demonstrated success authoring and defending CMC sections for major regulatory filings (INDa, BLA, MAA) and leading health authority inspections.
• Strategic thinker with the discipline and execution focus to translate vision into operational results.
• Skilled at leading through influence — particularly in remote and matrixed environments.
• Executive-level communication skills; equally effective with scientific peers, manufacturing partners, regulatory agencies, and senior leadership.
• High standards of quality, accountability, and urgency — with the resilience to thrive in a fast-paced cell & gene therapy field.
• Collaborative, team-oriented approach balanced with the decisiveness required of a senior technical authority.

Nice To Haves

• Technical expertise in cell therapy manufacturing processes and technologies is highly desirable.
• Experience in the biologics or viral vectors or vaccines will be considered.

Responsibilities

• 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.
• Work in close partnership with Quality, CMC Regulatory, Supply Chain, CMC Leadership, and participate in Change Controls and Technical Governance Committees.

Benefits

• We balance the expectation of being in the office while respecting individual flexibility.
• Commitment to lifelong learning, growth and development for all.
• An inclusive culture where you will connect different thinking to generate new and valuable opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree