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

AstraZeneca; Gaithersburg (MD); On-site; USD 217,000 - 325,000; Full time

Job summary

AstraZeneca seeks a Senior Director of Manufacturing Science and Technology (MSAT) to lead cell therapy manufacturing across a global network. You will oversee tech transfer, process validation, and both clinical and commercial manufacture, partnering with Manufacturing Operations, Quality, Supply Chain and QC teams.

You will build and guide MSAT teams, drive site strategy, and ensure regulatory compliance with cGMP and ICH guidelines while optimizing process robustness and throughput across

Qualifications

• 12+ years of progressive experience in cell therapy/biologics/ vaccines manufacturing or CMC leadership.
• Proven leadership of MSAT or manufacturing operations teams.
• Strong GMP and regulatory knowledge for clinical and commercial supply.
• Experience with tech transfer, process validation and scale-up in multicenter networks.

Responsibilities

• Define and execute the Site MSAT function strategy to enable development and supply objectives.
• Build and mentor site MSAT teams with deep GMP operations and process science expertise.
• Lead technology transfer, process validation and commercial supply readiness for programs.
• Drive CPV, PPQ readiness, and site readiness for clinical and commercial manufacture.
• Represent MSAT in CMC teams and regulatory interactions.

Skills

Leadership

Team building

Strategic planning

Cross-functional collaboration

Education

Bachelor's / Masters in relevant field

Job description

AstraZeneca is seeking a Senior Director of Manufacturing Science and Technology (MSAT) to serve as senior-technical leader for the Cell Therapy manufacturing sites across a global network of AstraZeneca. You will be responsible for receiving manufacturing process at the sites and supporting clinical manufacture, process validation and commercial manufacture at AstraZeneca’s internal manufacturing sites, partnering closely with Manufacturing Operations, Quality, Supply chain and QC Operations teams located at the manufacturing sites. This is a leadership position responsible for developing and managing MSAT teams located at the manufacturing sites.

Your group will own the cell therapy manufacturing support for the sites - from tech transfer of the clinical manufacturing process to the process validation, commercial manufacture, and post-approval process improvements specific to manufacturing sites - partnering with Global Manufacturing Science and Technology and Manufacturing Operationsteams.

Responsibilities

Team Leadership & Strategy

• Define and execute the Site 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 Site MSAT teams with deep expertise in cell therapy GMP operations and process science and technology.
• Serve as a core member of the site Manufacturing Operations team, contributing to long-range supply planning, risk mitigation, and operational excellence.
• Lead, develop and oversee late-stage and commercial process execution strategies at manufacturing sites to enable harmonization and quality and regulatory compliance.

Development and Manufacturing Interface

• Represent Site MSAT in technology transfer, process validation and commercial supply teams to ensure successful supply of cell therapy products.
• Represent Manufacturing Operations in the CMC team, ensuring high-quality and timely program deliverables (clinical & commercial supply, site approvals).
• Lead Clinical manufacture and PPQ readiness at the manufacturing site that includes material, facility, equipment, manufacturing systems, documentation and process operations readiness.
• Implement and maintain 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

Lifecycle Management

• Identify and implement process improvements that improve process robustness, cost of goods, plant throughput, and supply continuity within the boundaries of an approved or cleared clinical products.
• Proactively identify and mitigate technical and operational risks; drive lessons-learned cycles and standardization across sites and teams.

Regulatory & Quality Support

• Serve as the senior accountable Site MSAT leader for regulatory submissions - Pivotal INDa, BLA, MAA, and supplements - reviewing CMC sections to ensure alignment with the site operations.
• Lead site preparedness and technical support for health authority inspections and audits working closely with Quality and Manufacturing Ops teams.
• Partner with quality and regulatory to maintain full compliance with cGMP, ICH guidelines, and global regulatory expectations.
• Develop and defend sound scientific justifications for site operations (SOPs, MBRs, Manufacturing systems, Operation trainings), and any site-specific changes to the approved products.
• Lead site-specific Change Controls and ensure timely implementation and compliance working with global MSAT team.

Cross-Functional Partnerships

• Manufacturing Operations - align with site capability and readiness and provide routine support to enable flowless execution at the site
• Quality - ensuring process compliance and product quality standards at the site
• Supply Chain - align and support readiness for supply of the clinical and commercial products
• CMC Leadership - providing site MSAT input for tech transfer, clinical manufacture, process validation and commercial supply
• Governance - participate in Change Controls and Technical Governance Committees

You Will Work In Close Partnership With

• Manufacturing Operations - align with site capability and readiness and provide routine support to enable flowless execution at the site
• Quality - ensuring process compliance and product quality standards at the site
• Supply Chain - align and support readiness for supply of the clinical and commercial products
• CMC Leadership - providing site MSAT input for tech transfer, clinical manufacture, process validation and commercial supply
• Governance - participate in Change Controls and Technical Governance Committees

Qualifications

Education

• 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.

Experience

• 12+ years of progressive experience for cell therapy/biologics/vaccines modalities in technical development, manufacturing operation, CMC leadership or CMO management areas.
• Technical expertise in cell therapy manufacturing processes and technologies is highly desirable. Experience in the biologics or viral vectors or vaccines will be considered.
• Extensive background in GMP manufacturing operations, site readiness for clinical manufacture, process validation, and commercial supply, and site support for commercial products.
• Proven record of building, leading, and mentoring high-performing technical and cross-functional teams.

The annual base pay for this position ranges from $216,996.00 - $325,494.00. Our positions offer eligibility for various incentives - an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted

25-Sep-2026

Closing Date

08-Oct-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.