Senior Specialist Quality Control

Job Title: Senior Specialist - Quality Control

Career Level: D

About Singapore ADC:

About Singapo0re 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 addition it will be designed for carbon neutrality embedding sustainability into every aspect of operations and setting a new benchmark for environmentally responsible biologics manufacturing.

Introduction to role:

Are you ready to elevate Quality Control by embedding new technologies and shaping methods that speed safe reliable medicines to patients In this senior role you will connect scientific rigor with real-world delivery helping our manufacturing network release products right-first-time and at pace. Your expertise will resolve complex analytical and microbiological issues strengthen data integrity and improve for inspection readiness.

You will be the go-to technical expert for QC guiding method transfers advancing digital tools and mentoring colleagues so the lab runs smoothly every day. Can you see yourself turning innovation into standard practice while ensuring compliance never slips If so this is your opportunity to drive measurable improvements in cycle time cost of non-quality and product quality that patients depend on.

Accountabilities:

• Technology Introduction: Evaluate introduce and embed new QC instrumentation methods and systems to keep the laboratory current competitive and compliant.
• Industry Scouting and Proposal Development: Monitor emerging standards and innovations; develop clear proposals and business-cases for implementation that improve speed robustness and data integrity.
• Method Transfer Leadership: Lead analytical technology transfer of QC methodology into and out of Operations designing transfer protocols and strategies that are audit-ready and scalable.
• Analytical Excellence and Troubleshooting: Provide expert guidance to resolve non-routine testing instrumentation and methodology issues leve-raging digital tools to prevent recurrence.
• Training and Coaching: Build capability across the QC team through targeted training coaching and knowledge sharing on equipment operation digital QC systems and best-practice compliance.
• Multi-Functional Planning: Collaborate with Manufacturing Quality Assurance Regulatory Development and external partners to plan and implement QC operations that support reliable supply.
• Inspection Readiness and Support: Prepare documentation evidence and SMEs for regulatory inspections; respond to queries with clarity and data-driven rationale.
• Mentorship and Compliance Stewardship: Guide early-career team members on QC processes GxP expectations and data integrity principles reinforcing a culture of continuous improvement.

Essential Skills/Experience:

• Bachelor s degree or equivalent in a scientific dis-cipline
• Prior experience in a regulated laboratory environment conducting microbiological or analytical QC testing
• Experience learning and implementing newer digital tools and technologies related to QC reporting documentation and analysis
• Experience driving compliance management and relevant GxP

Desirable Skills/Experience:

• Experience in green field or brown field projects to setup Quality Control laboratories
• Experience in establishing QC operation system (procedures and processes) for product introduction and supply
• Experience in establishing site environmental monitoring program for clean room and clean utilities
• Proficient in test methods transfer or validation for incoming raw materials intermediates drug substance (mAb) and drug product (Fill and Finish)
• Experience in supporting in QC digital system (LIMS MODA 1Lab Empower and/or SAP) site implementation

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were 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 QC expertise powers a mission that turns breakthrough science into reliable supply for patients worldwide. You will work shoulder-to-shoulder with diverse experts using advanced analytics automation and lean practices to improve how medicines are tested and released. We combine bold ambitions with practical support valuing kindness alongside drive so you can take ownership try new ideas and see them scale across a global network. From reducing release times to advancing sustainability goals your contribution will be visible meaningful and amplified by teams who challenge and champion each other to do their best work.

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

Call to Action:

Step into a role where your technical leadership will modernize QC and accelerate life-changing medicines to patientstake the next move in your career today!

Date Posted

Closing Date

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.