Associate Director – Manufacturing Electronic Batch Record (MEBR)

Associate Director Manufacturing Electronic Batch Record (MEBR)

GCL : E

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 state-of-the-art 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 modern 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.

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 AstraZenecas global supply chain but also advance life-changing medicines for patients everywhere.

If youre 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

Accountable for establishing and leading the Electronic Batch Record (EBR) capability at site this role owns how manufacturing processes are translated into practical executable batch records within MES. The focus is on creating operator-friendly compliant records that enable efficient batch execution review-by-exception and accelerated release. The Associate Director leads a dedicated team to create manage and continuously improve electronic batch records securing a smooth transition from project and tech transfer into routine GMP manufacturing with a strong emphasis on right-first-time execution and robust data integrity. Working closely with Manufacturing QA MS&T/Engineering Digital/MES and Supply Chain the role drives performance through clear KPIs while maintaining high regulatory standards.

Accountabilities

• Lead the establishment and long-term ownership of the sites Manufacturing Electronic Batch Record (MEBR) capability within the MES EBR review defining the strategy standards and ways of working
• Serve as the MEBR owner during Basic Design and Detailed Design phases ensuring process requirements are accurately captured and translated into executable electronic batch records.
• Collaborate with Global IT and cross-functional partners to secure timely MEBR readiness for API manufacturing large molecule manufacturing aseptic filling and finished packing processes.
• Ensure a smooth transition from project/start-up and tech transfer into routine GMP manufacturing removing barriers to adoption and stabilising performance.
• Drive right-first-time MEBR design concepts that enable efficient batch execution future batch review and accelerated batch release.
• Champion compliance with cGMP occupational safety and local regulatory expectations in all aspects of MEBR design execution and lifecycle management.
• Plan manage and control overall allocation of resources for MEBR creation revision and review balancing quality speed and cost.
• Streamline and continuously improve the MEBR creation revision and review process using Lean principles and digital tools.
• Recruit develop and lead a high-performing MEBR team EBR review collaborate with the QA team to set up a review-by-exception process ensuring timely review of EBR with improved efficiency and at the right time.
• Define business needs for MEBR capability gain stakeholder alignment and translate these needs into specific resource and investment requirements.
• Coach and mentor team members to build deep expertise in EBR design GMP documentation and shopfloor execution.
• Develop senior-level relationships across the site and network to resolve issues quickly optimize business performance and identify future improvement opportunities.
• Own and drive KPIs across productivity quality safety schedule adherence and cost for the MEBR area using data to guide decisions.
• Lead the continuous improvement culture within the MEBR team and contribute to digital transformation initiatives across manufacturing.
• Act as a key voice in inspections and audits related to MES/EBR validation and data integrity ensuring readiness at all times.

Essential Skills/Experience

• Degree in Engineering Pharmaceutical Sciences or related field
• Strong experience in GMP manufacturing industry within large matrix organization
• Proven experience in batch record creation review and management in a GMP environment
• Deep understanding of shopfloor operations and process execution
• Experience working with electronic batch record systems (as a user/owner not IT developer)
• Strong knowledge of GMP documentation data integrity (ALCOA) and regulatory expectations
• Demonstrated leadership in transitioning from project/startup into commercial operations

Desirable Skills/Experience

• Advanced Credentials: Masters or MBA; certifications (Lean Six Sigma; Green Belt).
• Regulatory Engagement: Experience in FDA/EMA/MHRA/NMPA inspections defending MES/EBR validation and data integrity.
• Platform Depth: Advanced skills in PAS-X (master batch records parameter libraries review-by-exception workflows).
• Change Management: Leading adoption training and governance/template rollout across site or network.
• Data & Analytics: Use of EBR data and KPIs for CPV process capability and accelerated batch release.
• Multisite/Global: Collaboration with Global IT and cross-site teams to harmonize standards and deliver to quality/schedule/cost KPIs.

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.

AstraZeneca offers the chance to turn complex science into real-world impact at scale working with advanced digital technologies Lean practices and sustainable operations to deliver medicines faster and more affordably to patients worldwide. Teams are inclusive multigenerational and collaborative with leaders who invest in development encourage curiosity and support people to step up take ownership and build long-term careers across a truly global network.

Join a supportive and welcoming team of equals where diverse perspectives are valued learning never stops and every improvement made on the shopfloor can ripple out to patients and communities across the globe.

Ready to shape how electronic batch records power modern manufacturing and help bring medicines to patients faster Apply now!

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.