Senior Specialist - MSAT

Career Level:

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 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.

Introduction to role:

Are you ready to lead the science of manufacturing to deliver reliable, high-quality medicines to patients? As a Senior Specialist in MSAT, you will be the technical authority who strengthens the robustness of our biologics, API, and fill-finish processes, ensuring consistent performance from technology transfer through commercial supply. Your work will directly influence product quality, inspection readiness and supply reliability, making a measurable difference to patients and to our manufacturing network.

You will partner closely with the Process Lead and a cross-functional technology transfer team, owning critical validation and control strategies while driving data-driven monitoring and risk-based decisions. This is a role for a hands-on problem solver who thrive on sophisticated technical challenges. How will you bring your expertise to elevate process performance and accelerate the journey from molecule to medicine?

• Process Lifecycle Leadership:
  Own the development, review and approval of key technical and validation deliverables, including technology transfer strategies, validation strategies, risk assessments, control strategies, and lifecycle technical documentation management; ensure decisions are science- and data-based to secure process robustness and inspection readiness.
• Control Strategy Stewardship:
  Establish and maintain process control strategies by defining and monitoring critical quality attributes, critical process parameters, and process performance indicators to ensure process robustness, product quality, and continued process verification.
• Complex Investigations and CAPA Excellence:
  Lead sophisticated technical investigations and manufacturing support activities to enable robust root cause identification, risk assessment and implementation of effective corrective and preventive actions that prevent recurrence and protect supply.
• Regulatory and Audit Support:
  Prepare and present technical justifications and documentation for validation and process performance during inspections; act as a trusted point of contact for regulatory engagements.
• Cross-Functional Collaboration:
  
  Partner with Quality Assurance, Operations, Supply Chain, planning and purchasing, central project groups, other sites, development, and external suppliers to align technical goals with operational priorities and customer expectations.
• Technical Customer concern and Issue Resolution:
  Serve as the primary point of technical issue, resolving complex challenges or coordinating solutions with relevant departments and collaborators to maintain safe, compliant and efficient operations.
• Systems and Equipment Expertise:
  Apply advanced knowledge of manufacturing systems, equipment, and regulatory guidelines to drive effective problem-solving and continuous improvement across manufacturing and packaging processes.
• Coaching and Capability Building:
  Advise and mentor colleagues by sharing specialized expertise, strengthening team capabilities and promoting standard…