Manufacturing Production Specialist (Drug-Linker)

Job Title: Manufacturing Production Specialist (Drug-Linker)

GCL D

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 state-of-the-art 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 modern 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.

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.

Introduction to role:

Are you ready to bring a new high-containment facility online and turn pioneering science into diligent, right-first-time manufacturing? At our Singapore ADC campus, you will help transform technology and procedures into safe, compliant production of high‑potency drug-linker intermediates that enable life-changing medicines for patients.

This hands-on role sits at the heart of start-up and ongoing operations. You will assist in driving equipment qualification, operational readiness and on-floor support, then transition those foundations into robust routine GMP manufacture. Do you see yourself on the shopfloor connecting FAT/SAT insights to batch execution, solving problems in real time, and making every batch safer and better than the last?

Accountabilities:

Equipment Qualification and Start-Up: Support FAT/SAT, commissioning, and IQ/OQ/PQ for key production and containment systems including reactors, filter dryers, isolators, chromatography systems, HPLC, and solvent recovery equipment—ensuring systems are fit for purpose and aligned with GMP, operational safety, and protective measures standards.

Operational Readiness: Contribute to SOPs, batch record design, material flow, and operator training. Provide technical input on containment strategies, material transfers, and safe handling of solvents, powders, intermediates and waste, building the foundation for reliable campaign execution.

On-Floor Manufacturing Support: Drive line readiness, setup and changeovers, troubleshoot deviations, and maintain high-quality GMP documentation. Ensure materials and product outputs meet specifications for seamless transfer to conjugation.

Accountability for Safety and Containment: Coordinate with EHS to ensure cGMP, process safety and local regulatory expectations are met. Participate in risk assessments, hazard analyses and ALARP evaluations to ensure the secure management of high‑potency compounds.

Cross-Functional Collaboration: Coordinate with Engineering, QA, Validation, PT&D, Supply Chain and external vendors to accelerate qualification, validation and handover from project phase into routine operations. Ensure clear, timely communication and effective equipment and documentation transfers.

Continuous Improvement and Digital Enablement: Find opportunities to improve reliability, efficiency, documentation quality, operator usability and containment performance. Support paperless ways of working, automation and simplification of shopfloor processes, applying lessons learned and root cause analysis to strengthen operational robustness.

Quality Systems Engagement: Prepare, review and implement qualification protocols and test records. Initiate and support deviations, investigations, CAPAs and change controls to maintain safety, high standards of quality and conformity.

Essential Skills/Experience:

• Bachelor’s degree in Chemical Engineering, Organic Chemistry, Pharmaceutical Engineering, Mechanical Engineering, or a related subject area.
• 5–8 years of experience in small molecule GMP operations, preferably involving potent compounds, API synthesis, or high-containment manufacturing.
• Experience working with high-potency containment technologies, such as isolators, split butterfly valves, rapid transfer ports (RTPs), and closed systems.
• Hands-on experience supporting equipment qualification and validation, including exposure to FAT, SAT, IQ, OQ and PQ activities.
• Sound understanding of GMP documentation, deviation management, change control, CAPA, and validation principles.
• Demonstrated commitment to safety, quality, and delivery in a regulated manufacturing environment.
• Strong written and verbal communication skills, with good attention to detail.
• A safety-first attitude with awareness of operator experience and usability in high-containment operations.
• Able to balance strategic-thinking with practical execution, and comfortable working in a start-up environment.
• Strong cross-functional and cross-cultural collaboration skills.
• Demonstrated learning agility and a commitment to continuous improvement, innovation, and operational excellence.
• Willingness and ability to travel and spend short periods based near vendor sites, as required to support project and qualification activities.

Desirable Skills/Experience:

• Experience supporting the start-up and operational readiness of a new manufacturing facility or production area.
• Experience in ADC linker or payload synthesis, or the manufacture of highly potent intermediates.
• Familiarity with containment controls, material transfer systems, cleaning validation, and equipment performance verification.
• Exposure to process validation, technical transfer, manufacturing investigations, deviation management, or production support projects.
• High resilience and the ability to work effectively through ambiguity, change, and evolving business needs.
• Familiarity with Singapore regulatory requirements and global GMP expectations.
• Experience with Lean Six Sigma, structured problem solving, or validation practice.

Why AstraZeneca:

Join a global, science-led company where your work in high-containment manufacturing directly supports innovative medicines reaching more patients. You will collaborate with engineers, scientists and operations experts—often bringing unexpected teams into the same room to unlock bold thinking—while using modern tools, data and automation to improve on safety, quality and reliability. We value kindness alongside ambition, and we invest in your growth with practical, continuous learning that helps you master new skills and shape your long-term career as our pipeline and capabilities expand.

Call to Action:

If you are ready to turn start-up momentum into safe, reliable production with tangible patient impact, step forward and shape how we make a difference from Singapore.

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.