Senior Specialist - MSAT

AstraZeneca plc

Singapore

Ibrido

SGD 120.000 - 180.000

Tempo pieno

2 giorni fa
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Office flexibility

Descrizione del lavoro

AstraZeneca plc is seeking a Senior Specialist in MSAT for our Singapore biologics campus. You will lead manufacturing science and technology activities across API, biologics and fill-finish processes to ensure robust, compliant performance.

You will partner with cross-functional teams to deliver risk-based decisions, validation, and continuous improvement, shaping global supply and product quality for patients worldwide. This role supports hybrid office presence with in-person collaboration.

Competenze

  • Degree in technical or scientific field or equivalent experience.
  • Extensive experience in regulated manufacturing environments.
  • Strong knowledge of GMP, SHE, SOPs and compliance frameworks.
  • Experience applying project management principles.

Mansioni

  • Lead technology transfer and validation deliverables to ensure process robustness.
  • Define and monitor control strategies and process parameters.
  • Investigate technically complex issues and drive CAPA effectiveness.
  • Support regulatory inspections with technical justifications and documentation.
  • Collaborate across QA, Operations, Supply Chain and external partners.
  • Drive digital adoption and data-driven decision making across the team.

Conoscenze

GMP knowledge
Problem solving
Cross-functional
Communication

Formazione

Technical/Scientific degree

Descrizione del lavoro

Job Title: Senior Specialist - MSAT

Career Level: D

About Singapore ADC Site:

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?

Accountabilities:
  • 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 processes across the function.
  • Change Management and Innovation: Support the implementation of changes, mitigate risks, and facilitate the integration of innovative technologies or technical methodologies that enhance throughput, quality and cost effectiveness.
  • Risk-Based Decision Making: Lead risk assessments and technical decisions concerning materials, processes, suppliers and compliance, and call out significant quality, safety, compliance, supply or operational risks as appropriate.
  • Digital Adoption and Insights: Engage teams to adopt digital solutions based on needs and plans that have been cascaded down, and track adoption and effectiveness; communicate technical insights and recommendations to both technical and non-technical customers, including senior leadership.
  • Continuous Learning: Stay informed on industry trends and organizational developments to keep practices current and drive progressive improvements in process performance.
Essential Skills/Experience:
  • Degree in technical or scientific field OR 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
  • Strong knowledge of GMP, SHE, SOPs, compliance frameworks
  • Experience in applying project management principles
  • Understanding of manufacturing and engineering landscapes
  • Ability to explain technical decisions to diverse collaborators
Desirable Skills/Experience:
  • Hold or pursue recognised professional certification
  • Broad understanding of product supply chain
  • Knowledge of interdependence between machinery / equipment, components/ materials, and process performance
  • Ability to connect supply chain operations with process optimization

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca:

Here, your technical leadership powers real-world impact. You will work with innovative science and digital tools in a collaborative environment where unexpected teams come together to rethink how medicines are made, scaled and sustained. We value kindness alongside ambition, and we back bold ideas with investment, mentoring and exposure, from Lean practices to smart, data-enabled manufacturing. Your decisions will help shape reliable supply and quality for patients, contribute to our sustainability commitments, and open doors to a global network where careers evolve as fast as our pipeline.

Date Posted

15-Oct-2026

Closing Date

28-Oct-2026

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.

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