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Senior MSAT Specialist, Materials

astrazeneca · Singapore

New
Senior 🇬🇧 English
GMP SHE SOPs Extractables and leachables Material qualification Single-use systems

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. Within the Manufacturing Science and Technology team, this senior role defines the standards for manufacturing materials and single-use systems, qualifying and managing product-contact components across biologics, API and fill-finish operations. It works closely with the Director of Product Technical Transfer and cross-functional teams.

Key responsibilities

  • Lead material qualification, lifecycle management and supplier assessment programmes to ensure compliance, product quality and manufacturing robustness.
  • Run risk assessments, technical evaluations and qualification activities for materials, product-contact components and single-use systems, with audit-ready documentation.
  • Drive extractables and leachables strategies, material compatibility assessments and scientific justifications.
  • Evaluate and implement new materials, technologies and supplier solutions.
  • Act as the primary point of technical escalation and coordinate cross-functional solutions.
  • Support change implementation and integration of new technologies, aligned with quality and business priorities.
  • Mentor MSAT material specialists, set technical standards and best practices, and coach colleagues.
  • Collaborate with regulatory groups, Quality, Operations, Supply Chain, planning and purchasing, and external suppliers and agencies.
  • Communicate technical insights to technical and non-technical stakeholders, including senior leadership, and promote digital tools and data-driven decision making.

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.
  • Ability to explain technical decisions to diverse stakeholders.

Required skills

  • Strong knowledge of GMP, SHE, SOPs and compliance frameworks.
  • Experience applying project management principles.
  • Understanding of manufacturing and engineering landscapes.
  • Desirable: recognised professional certification, broad supply chain knowledge, and the ability to link supply chain operations with process optimisation.

The role involves an average of at least three days per week in the office, with flexibility. The closing date is 31 October 2026.

Questions fréquentes

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Source : ats:workday

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Published 2 days ago

Expires 1 month from now

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astrazeneca

Singapore