Senior Specialist - MSAT

About the role

AstraZeneca is building its first biologics manufacturing campus in Singapore, a USD 1.5 billion investment covering small-molecule API production, monoclonal antibody manufacturing, conjugation, sterile fill-and-finish and final secondary packaging. Within the Manufacturing Science and Technology team, the Senior Specialist in MSAT strengthens the robustness of biologics, API and fill-finish processes, from technology transfer through commercial supply. The role partners with the Process Lead and a cross-functional technology transfer team, owning critical validation and control strategies.

Key responsibilities

• Own the development, review and approval of key technical and validation deliverables, including technology transfer and validation strategies, risk assessments, control strategies and lifecycle technical documentation
• Establish and maintain process control strategies by defining and monitoring critical quality attributes, critical process parameters and process performance indicators
• Lead technical investigations and manufacturing support to identify root causes and implement effective corrective and preventive actions
• Prepare technical justifications and documentation for validation and process performance during inspections, and act as a point of contact for regulatory engagements
• Partner with Quality Assurance, Operations, Supply Chain, planning and purchasing, other sites, development and external suppliers
• Serve as the primary point of contact for technical issues and coordinate solutions with relevant departments
• Apply knowledge of manufacturing systems, equipment and regulatory guidelines to drive continuous improvement
• Mentor colleagues, support change implementation and mitigate risks
• Lead risk assessments on materials, processes, suppliers and compliance, and call out significant quality, safety, compliance, supply or operational risks
• Promote digital adoption, track its effectiveness and share technical insights with technical and non-technical customers, including senior leadership

Required profile

• Degree in a technical or scientific field, or a technical/associate/vocational diploma with equivalent experience
• Extensive experience in regulated manufacturing environments
• Deep expertise in manufacturing or packaging operations
• Proven ability to resolve complex technical issues
• Understanding of manufacturing and engineering landscapes
• Ability to explain technical decisions to diverse collaborators

Required skills

• Strong knowledge of GMP, SHE, SOPs and compliance frameworks
• Experience applying project management principles
• Desirable: recognised professional certification, broad understanding of product supply chain, and knowledge of how machinery, components, materials and process performance depend on each other

The role works on average at least three days per week from the office, with flexibility. The closing date is 28 October 2026.