Associate Director MSAT Process Technical Lead

Job Title: Associate Director - MSAT Process Technical Lead

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 addition it will be designed for carbon neutrality embedding sustainability into every aspect of operations and setting a new benchmark for environmentally responsible biologics 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 AstraZenecas global supply chain but also advance life-changing medicines for patients everywhere.

If youre 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 Leads for different manufacturing units 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 filling including lyophilization or Monoclonal antibody Manufacturing and Conjugation or High Potent API manufacturing
• 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.
• Fixing 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 datadriven decisions.
• Process analytical technology (PAT): Evaluate implement and maintain PAT and nextgeneration 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:

• 710 years in biopharma MSAT/Process Engineering/Validation with direct leadership across one or all manufacturing units: mAb Drug Substance Conjugation High Potent API and sterile Drug Product (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 one or all manufacturing units: aseptic filling and lyophilization upstream and downstream biologics manufacturing conjugation and high potent API.
• Facility lifecycle experience in Design qualification and validation in one or all manufacturing units: Drug Substance API or DP facilities; exposure to singleuse 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.

Desirable Skills/Experience:

• Advanced degree or equivalent experience (PhD or MSc or equivalent experience) in Chemical Engineering Pharmaceutical Sciences Chemistry or a related field.
• Proven industry experience in antibodydrug conjugate or high potent API manufacturing and containment including OEB/OEL assessments and closed-transfer systems.
• 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 -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca:

Here your expertise turns complex science into medicines that reach more patients faster and more affordably. You will work with modern manufacturing technologies and digital tools alongside diverse problem-solvers who combine rigor with curiosity to push boundaries. We bring different perspectives together at speed apply Lean thinking to sharpen execution and anchor every decision in sustainabilitycontributing to bold carbon goals while building your skills across a global network. We value kindness alongside ambition giving you the support to lead learn and create visible impact across the molecule-to-medicine journey.

Call to Action:

If youre ready to lead and take technical ownership of one of the ADC manufacturing units and shape how life-changing medicines are made take the next step today!

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.