Lead Process Subject Matter Expert (SME) - Small Molecule Synthetic Chemical API

Job Title: Lead Process Subject Matter Expert (SME) - Small Molecule Synthetic Chemical API​

Career Level: F

Introduction to role:

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 on one campus

• Small molecule - synthetic 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 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 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 AstraZeneca’s global supply chain but also advance life-changing medicines for patients everywhere.

If you’re ready to shape the future of medicines and be part of a once-in-a-generation project, we want you on our team.

We are recruiting a lead SME to convert business requirements into safe, reliable, and efficient small molecule synthetic chemical API manufacturing capability. In this pivotal role, you will own the end-to-end technology journey - from design through commissioning and successful operation - so patients gain access to innovative medicines.

You will lead a small team of Process SMEs to coordinate internal partners, A&E design companies, and technology suppliers to deliver systems right-first-time, ensuring a smooth handover to operations and unlocking long-term business value.

A key part of your role is to advise the Project Manager (PM) and the Project Technical Manager (PTM) about options and recommended actions to deliver the best results in the small molecule synthetic chemical API area.  This will ensure that AstraZeneca can hold suppliers to account and challenge where appropriate

Your leadership will align technology choices with GMP standards, Lean practices, and our environmental ambitions, reducing risk while delivering compliance and performance.

Accountabilities:

• Technical Ownership: Set the technical direction and hold overall accountability from initial concept through to successful operation for the assigned process technology area. Provide technical governance to the project delivery organization throughout the project lifecycle, assessing the design and the capabilities of our project Engineering partners and implementing relevant standards where appropriate. Act as the technical reference within your area. Build connections inside and outside the company to keep up-to-date on technical solutions. Present technical solutions and options to senior leadership, project sponsors and other AstraZeneca business units.
• Team Leadership: Ensure balanced resource allocation and effective coordination of the Process SME team across all relevant work packages. Escalate issues which can’t be resolved locally to the PTM in a timely manner and collaborate to resolve them.
• Design Review and Acceptance: Be accountable for the technical input into the Design Review process and ensure that project business objectives can be achieved; attend relevant pre-FATs, FATs, site walkdowns and SATs to ensure technology meets URS requirements, including witnessing critical technology testing and authorization to release equipment from supplier to AstraZeneca site, where appropriate.
• Collaborative Leadership: Establish trusted relationships with all key internal and external stakeholders and act as Technical Decision maker for your scope to ensure technology solutions meet all business performance requirements, including safety, compliance and capacity.
• Documentation Governance: Review and approve key technical documents including URSs, PIDs, DQs, FAT, and SAT protocols.
• Supplier Selection: Coordinate with AstraZeneca Global Procurement to identify and select the most appropriate suppliers for critical packages.
• Commissioning and Qualification: Assist in the planning and execution of startup and verification tasks; offer technical assistance to facility, equipment and systems throughout the startup and verification phases.
• Handover and Stabilization: Work closely with the site receiving team to prepare for technology handover, ensuring smooth transition into beneficial operation.
• Lean and Change Leadership: Using continuous improvement and organizational change tools, provide input to process improvement programs sponsored by GERE or other senior collaborators.
• Champion environmental sustainability as part of the design process, to ensure that AZ achieves its future targets.
• Risk Management: Lead the technical input to process risk assessments (HAZOP, FMEA) to establish and deliver safe process operations and compliance with quality standards.
• Audits and Compliance: Complete facility technical audits both internal and external in your area of specialty, to ensure consistency across the AstraZeneca network and address any non-compliance with AstraZeneca and industry cGMP standards.

Essential Skills/Experience:

• Bachelor’s degree in chemical engineering or equivalent, with significant experience in small molecule Synthetic API manufacturing technology
• Collaboration experience internal and external on process technology and shaping the direction of the technology of the future
• Extensive experience and in-depth technical knowledge in synthetic small molecule processes and operation
• Experience of leading small teams
• Identification, translation into design and delivery of Engineering Technologies 
• Ability to set technical direction for the design
• Good communication skills, with the ability to form a rational technical argument and to communicate at all levels Strong communication and stakeholder engagement skills with the ability to form rational technical arguments and engage at all levels, showing effective internal/external collaboration and ability to influence stakeholders.
• Effective supplier relationships, driving value and accountability Proven supplier relationship management by driving value and accountability
• Demonstrates a holistic approach when solving technical problems or addressing business requirements
• Process design and installation experience
• Experience in the specification, procurement, installation, start up, commissioning and qualification of equipment in a licensed GMP commercial plant
• Experience with capital project delivery from business case development through project execution and current GMP regulations Strong track record in capital project delivery from business case development through execution, ensuring adherence to internal and external standards
• Ability to drive and manage change and optimize designs to meet set performance criteria.
• Ability to ensure adherence to relevant internal and external standards
• Demonstrated practitioner of practical problem-solving
• Demonstrated experience in SHE/risk assessment, ensuring safe and compliant operations.

Desirable Skills/Experience:

• Worked with or in PT&D, R&D
• Digital solution integration
• Lean Manufacturing certification or Six Sigma Green Belt
• Chartered or Professional Licensed Engineer in a related discipline or equivalent
• Operational experience - both Production and Engineering

Work location

When we put unexpected teams in the same room, we ignite daring 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 bold world.

Why AstraZeneca:

Here, your engineering expertise directly translates into medicines reaching more people, faster. We bring unexpected teams together to fuel daring thinking, pairing modern science with focused execution and Lean practices to move from molecule to medicine with speed and care. You will join an inclusive network that values understanding alongside ambition, where your technical decisions build a global manufacturing footprint and a sustainability agenda backed by real investment - giving you the platform to lead, learn and make a lasting impact.

Call to Action:

Take charge of designing and delivering manufacturing capability for small molecule synthetic chemical APIs for novel ADC medicines. Translate critical engineering efforts into life-changing outcomes. Express your interest today and help build the future patients are waiting for!

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.