MSAT Specialist – Biologics Manufacturing
astrazeneca · Singapore
Job description
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. As an MSAT Specialist in the Manufacturing Science and Technology team, you will strengthen process robustness across biologics, API and fill-finish operations, driving process validation, control strategy implementation and continued process verification so facilities stay inspection-ready and supply stays on time.
Key responsibilities
- Develop, review and execute technology transfer plans, validation documentation, risk assessments, control strategies and lifecycle technical records.
- Implement and maintain control strategies by monitoring critical quality attributes, critical process parameters and process performance indicators.
- Analyze process data and trends to spot risks, deviations and improvement opportunities early.
- Lead root cause analysis and corrective and preventive actions (CAPA).
- Prepare technical documentation and data summaries to support inspections and regulatory filings.
- Provide technical guidance across manufacturing and packaging to improve yield, throughput and reliability.
- Resolve technical issues and support multi-functional problem solving.
- Execute approved process changes, share lessons learned and standardise practices across sites and partners.
- Support the adoption of digital solutions and communicate technical findings clearly to technical and non-technical audiences.
Required profile
- Degree in a technical or scientific field, or a technical/associate/vocational diploma with equivalent experience.
- Relevant experience in regulated manufacturing environments.
- Demonstrated expertise in manufacturing or packaging operations and proven ability to resolve complex technical issues.
- Desirable: recognised professional certification, commitment to formal technical development, awareness of machinery/equipment and supply chain operations.
Required skills
- Practical knowledge of GMP, SHE, SOPs and compliance frameworks.
- Hands-on experience with continuous improvement strategies and tools.
- Ability to engage diverse audiences with clear, effective communication.
The role involves in-person work at least three days per week, with flexibility. The closing date is 28 October 2026.
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Published 2 hours ago
Expires 1 month from now
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astrazeneca
Singapore