Associate Director – Process Technical Lead for Drug Product Aseptic Manufacturing

Job Title: Associate Director –  Process Technical Lead for 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/buildings in one 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 intelligence. In addition, it will be designed for carbon neutrality, embedding sustainability into every aspect of operations and setting a new benchmark for environmentally responsible biologic's manufacturing. 

In Manufacturing Science 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 AstraZeneca’s global supply chain but also advance life-changing medicines for patients everywhere. 

If you’re ready to shape the future of biologics and be part of a once-in-a-generation project, we want you on our team. 

We are recruiting Manufacturing Science and Technology Process Technical Lead for Drug Product Aseptic Manufacturing unit to provide technical leadership, input into process design and scale up and technology 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: Provide subject-matter expertise for Aseptic manufacturing process including 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. 

• Troubleshooting and deviation management: Lead complex investigations across manufacturing units, apply structured root cause analysis and 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: Identify and Lead and implement improvements to increase yield, reduce variability, and lower cost; assess and deploy new 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 drive data driven decisions. 

• Process analytical technology (PAT): Evaluate, implement, and maintain PAT and next generation monitoring/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. 

Essential Skills/Experience: 

• 7–10+ years in biopharma MSAT/Process Engineering/Validation with direct leadership in Drug Product manufacturing (aseptic filling and lyophilization). 

• Demonstrated track record in 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 technical end to end leadership in aseptic filling and lyophilization. 

• Facility lifecycle experience in Design, qualification, and validation in  DP manufacturing; exposure to single use technologies and closed processing. 

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

• Ability to define business needs, gain approval and translate these needs into specific resource requirements. 

• Proven ability to drive compliance with cGMP, occupational safety and local regulatory expectations. 

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

Expertise required: (MustHaves)  

Aseptic Filling & Technical Leadership 

• 7–10+ years in biopharmaceutical aseptic manufacturing and sterile operations. 

• Proven end-to-end technology transfer experience for aseptic filling (PD → GMP site → CMO). 

• Expertise in 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 ( peristaltic pumps, time pressure systems). 

• Isolators,  EM controls (ISO 5/7), and contamination control. 

• Vial filling, depyrogenation, 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 

• Expertise in aseptic unit operation design : media fills, line interventions, process risk analysis. 

• Skilled in filtration validation, filter sizing,  and integrity test limits. 

• Competent in line setup optimization, line speed tuning, mixing, sterile transfers, and hold time studies. 

• Expertise in 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, or a related field. 

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

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

• Demonstrated expertise in QbD, DOE, and statistical process control; proficiency with statistical software for process monitoring and 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 medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.