Director, Product Technical Transfer

Job Title: Director Product Technical Transfer

Career level: F

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
• 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 (MS&T) we are recruiting a Technical Transfer Director to provide multi-functional leadership for endtoend technology transfer of antibodydrug conjugates at Singapore Site. You will be the trusted SME and leader who defines and implements integrated control strategies and partners across Safety Process Development Engineering Manufacturing and Quality to enable robust compliant and efficient ADC manufacturing. 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.

Accountabilities:

• Technical ownership: Provide leadership and subjectmatter expertise for ADC manufacturing across the value chain including monoclonal antibody drug substance linker/payload and HighPotency API (HPAPI) handling conjugation operations and sterile drug product (aseptic filling and lyophilization).
• Lead the team design structure and establish efficient ways of working
• Provide product life cycle management and oversight post technical transfer completion
• Process design scaleup and control strategy: Translate development knowledge into detailed process designs and characterization plans for mAb conjugation High Potent API and Aseptic Drug Product Manufacturing. Define and implement the integrated control strategy (CQAs/CPPs IPCs) to ensure robust validation and successful technology transfer.
• Technology transfer leadership: Plan and lead tech transfers from Development to manufacturing sites and between AZ sites/CMOs; author transfer strategies gap assessments FMEAs comparability/bridging protocols and success criteria specific to ADCs.
• Regulatory: Author or support CMC dossier sections supporting technology transfer validation and lifecycle management for ADCs; act as SME during regulatory inspections and health authority queries.
• Validation and PPQ/CPV: Define phaseappropriate validation strategies for ADC operations including PPQ approaches and continued process verification metrics tailored to ADC critical quality attributes.
• Strategic improvements and cost/efficiency: Identify lead and implement improvements that increase yield reduce variability and lower cost across ADC Manufacturing Processes.
• Advanced analytics and digital tools: Use statistical tools and digital platforms (e.g. multivariate analysis predictive models) to build process understanding monitor CPPs/CQAs detect drift and enable datadriven decisions across sites.
• Project management and governance: Serve as project manager for complex ADC tech transfers; provide technical direction and governance align scope and timelines integrate technical work across manufacturing nodes.
• Global networking and collaboration: Collaborate with global colleagues in Development Operations and Regulatory; build networks to share standards and accelerate ADC platform and lifecycle improvements.

Crucial 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).
• Expertise 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.
• Strong 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.
• 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.
• 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.
• 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 unleash 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.

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.