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

AstraZeneca is seeking a Senior Director ofManufacturing Scienceand Technology (MSAT) to serve as senior-technical leader fortheCell Therapy manufacturingsitesacross a global networkofAstraZeneca.You willbe responsible forreceiving manufacturing process at the sites and supporting clinical manufacture, processvalidation and commercial manufacture at AstraZeneca’s internal manufacturing sites, partnering closely withManufacturing Operations, Quality,Supplychain and QC Operations teamslocated at the manufacturing sites.This is a leadership position responsible for developing and managingMSAT teamslocated at the manufacturing sites. 

Your group will own thecell therapy manufacturing support for the sites— from tech transfer of theclinical manufacturing process totheprocess validation,commercial manufacture, and post-approval process improvements specific to manufacturing sites —partneringwithGlobal Manufacturing Scienceand Technologyand Manufacturing Operations teams. 

Responsibilities 

Team Leadership & Strategy 

• Define and execute theSiteMSAT function strategy aligned withCell Therapy Technical Operationsto enabledevelopmentand supplyobjectives across clinical and commercial stages. 

• Build, mentor, and developa high-performingSiteMSAT teams with deepexpertise incelltherapyGMP operations and process science and technology.  

• Serve as a core member of thesite 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 

• RepresentSite MSAT intechnology transfer,processvalidationand commercial supplyteams to ensure successfulsupply of cell therapy products. 

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

• Lead Clinical manufacture andPPQ readinessat the manufacturing sitethat includesmaterial, facility, equipment,manufacturing systems,documentationand process operations readiness. 

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

 Lifecycle Management 

• Identify and implement process improvements thatimprove processrobustness,cost of goods, plantthroughput, and supply continuity within the boundaries ofan approvedor cleared clinicalproducts. 

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

Regulatory & Quality Support 

• Serve as the senior accountableSiteMSAT leader for regulatory submissions —PivotalINDa, BLA, MAA, and supplements —reviewing CMC sectionsto ensurealignment with the site operations. 

• Leadsite preparedness and technical support for health authority inspections and audits working closely with Quality and Manufacturing Ops teams.  

• Partner withquality and regulatory tomaintain full compliance with cGMP, ICH guidelines, and global regulatory expectations. 

• Develop and defend sound scientific justifications forsite operations (SOPs,MBRs, Manufacturing systems, Operation trainings), andanysite-specific changes to the approved products. 

• Leadsite-specificChange Controls and ensuretimely implementation and complianceworking withglobal MSAT team. 

Cross-Functional Partnerships 

You will work in close partnership with: 

• Manufacturing Operations –align with site capability andreadiness andprovideroutine support to enable flowlessexecution at the site 

• Quality — ensuring process compliance and product quality standards at the site 

• Supply Chain —align and support readiness forsupply of theclinical and commercial products 

• CMC Leadership — providingsiteMSAT input fortech transfer,clinical manufacture, processvalidation and commercial supply 

• Governance —participate inChangeControls andTechnical 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 experiencefor cell therapy/biologics/vaccinesmodalities in technicaldevelopment,manufacturing operation,CMCleadership orCMO managementareas. 

• Technicalexpertise 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 clinicalmanufacture,process validation,and commercial supply, and site support forcommercial 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

Closing Date

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.