Associate Director – Process Technical Lead for Drug Product Aseptic Manufacturing

Job Title: Associate DirectorProcessTechnical Leadfor Drug Product Aseptic Manufacturing

Career level:E

Introduction to role:

Be part of history in the making. AstraZeneca is building its first biologics manufacturing campus in Singapore a groundbreaking USD 1.5 billion investment that will serve as a global hub for innovation and excellence.

This innovative facility will deliver end-to-end Antibody-Drug Conjugate (ADC) capabilities with different manufacturing units/buildingsinone campus:

• Small molecule- chemical API production

• Large molecule- monoclonal antibody manufacturing

• Conjugation

• Fill-and-finish operations including sterile filling and lyophilization

• Final secondary packaging

The campus will be equipped with innovative digital and automation infrastructure enabling autonomous manufacturing powered by artificial addition it will be designed for carbon neutrality embedding sustainability into every aspect of operations and setting a new benchmark for environmentally responsiblebiologicsmanufacturing.

InManufacturingScience and Technology Team we are looking for passionate individuals with relevant experience who thrive in dynamic environments and bring a make-it-happen attitude. Joining us means contributing to a project that will not only transform AstraZenecas global supply chain but also advance life-changing medicines for patients everywhere.

Ifyoureready to shape the future ofbiologicsand be part of a once-in-a-generation project we want you on our team.

We are recruitingManufacturingScience and Technology Process TechnicalLead for Drug Product Aseptic Manufacturingunit to provide technical leadership input into process design and scaleup andtechnology transfer.

You will be the trusted subject-matter expert who defines CQAs and CPPs engineers control strategies and partners across Safety Process Development Engineering Manufacturing and Quality teams.

Accountabilities:

• Technical ownership: Providesubject-matterexpertiseforAsepticmanufacturing processincluding lyophilization.

• Process design scale-up and control strategy:Input into Detailed process design and characterization; define the integrated control strategy to ensure robust process validation and technology transfer.

• Technology transfer leadership: Plan and implement tech transfers from Development to site and between AZ sites/CMOs; author transfer strategies gap assessments FMEAs comparability protocols and success criteria.

• Troubleshootingand deviation management: Lead complex investigations across manufacturing units apply structured root causeanalysisand implement effective CAPAs.

• Regulatory: Author or support regulatory dossier sections supporting technology transfer validation and lifecycle product management; act as SME during regulatory inspections.

• Strategic improvements and cost/efficiency:Identifyand Lead and implement improvements to increase yield reduce variability and lower cost; assess and deploynew technologies automation and analytics that enhance process robustness.

• Advanced analytics and digital tools:Apply statistical tools and digital platforms such as multivariate analysis statistical process control and predictive modeling to build process understanding monitor CPPs/CQAs detect drift and drivedata drivendecisions.

• Process analytical technology (PAT): Evaluate implement andmaintainPAT andnext generationmonitoring/control solutions to enhance process understanding reduce cycle time and strengthen the overall control strategy.

• Project Management and Governance: Act as Project Manager for complex technical projects; provide technical direction and governance across the project management network agreeing scope and integrating technical work across the lifecycle.

• Global Networking and Collaboration: Ensure effective collaboration across sites and customers in the region and with global colleagues; build networks across global operations development and international regulatory affairs.

• Strategic Efficiency: Support strategic plans for process and plant improvements to increase efficiency and drive down costs.

EssentialSkills/Experience:

• 710 years in biopharma MSAT/Process Engineering/Validation with direct leadershipinDrug Productmanufacturing(aseptic filling and lyophilization).

• Demonstratedtrack recordin planning and execution of technical transfers to/from development internal sites and CMOs; authoring transfer strategies FMEAs comparability protocols success criteria and knowledge capture.

• Demonstrated experience in technicalend to endleadership in aseptic filling and lyophilization.

• Facility lifecycle experience in Design qualification and validationin DPmanufacturing; exposure tosingle usetechnologies and closed processing.

• Demonstrated ability to translate developmentprocessinto robust commercial processes; define CQAs/CPPs control strategy and implement lifecycle product management.

• Ability to define business needs gainapprovaland translate these needs into specific resource requirements.

• Proven ability to drive compliance with cGMP occupationalsafetyand local regulatory expectations.

• Experience inselection qualification and lifecycle management of single-use materials; evaluation of material compatibility and implementation of closed-transfer to reduce contamination risk.

Expertiserequired: (MustHaves)

Aseptic Filling & Technical Leadership

• 710 years in biopharmaceutical aseptic manufacturing and sterile operations.

• Provenend-to-endtechnology transfer experience for aseptic filling (PD GMP site CMO).

• Expertisein filling process design: sterile flow paths hold times filtration strategy equipment configuration filling accuracy and process characterization.

Aseptic Processing Expertise

• Strong technical knowledge of:

• Sterile filtration and integrity testing (pre/postuse).

• Filling technologies( peristalticpumpstime pressuresystems).

• Isolators EMcontrols (ISO 5/7) and contaminationcontrol.

• Vial fillingdepyrogenation stoppering and capping.

• Container closure integrity (CCIT) and core sterility assurance concepts.

Regulatory & Validation

• Led PPQ/process validation for aseptic filling.

• Deep understanding of CQAs/CPPs and aseptic process control strategies.

• Experience authoring CMC regulatory submissions (IND/IMPD BLA/MAA comparability protocols).

• Served as SME during regulatory inspections (FDA/EMA/PMDA/HSA) for aseptic processing filtration sterilization and contamination control.

Technical Skills & Investigations

• Expertisein aseptic unit operationdesign :mediafills line interventions process risk analysis.

• Skilled in filtration validation filtersizing andintegrity test limits.

• Competent in line setup optimization line speed tuning mixing sterile transfers andhold timestudies.

• Expertisein lyophilization process and technology transfer

• Strong command of aseptic validation frameworks (Annex 1 (2022) FDA Aseptic Processing Guidance).

• Lead investigator for: Sterility risks/failures; Environmental monitoring (EM) excursions

• Fill weight variability; Particulate contamination; Filtration failures/integrity testing deviations

Desirable Skills/Experience:

• Advanced degree or equivalent experience (PhD or MSc or equivalent experience) in Chemical Engineering Pharmaceutical Sciences Chemistry ora relatedfield.

• Implementation of inline/online analytics soft sensors and integration with DCS/MES andRealtimerelease testing frameworks.

• Familiarity with MES historians PI/DeltaV batch recipe management and data integrity.

• DemonstratedexpertiseinQbD DOE and statistical process control;proficiencywith statistical software for processmonitoringand analysis.

• Excellent technical writing and presentation skills; ability to distill complex science into clear committed decisions.

When we put unexpected teams in the same room we fuel bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work atpaceand challenge perceptions.Thatswhy we work on average a minimum of three days per week from the office. But thatdoesntmeanwerenot flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.