Associate Director, Drug Substance Tech Transfer Lead

Associate Director, Drug Substance Tech Transfer Lead

1. 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 pioneering 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 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 biologics and be part of a once-in-a-generation project, we want you on our team

2. Introduction to role:

Are you ready to lead complex biologics drug substance technology transfers that safeguard reliable supply for patients worldwide? This role puts you at the center of bringing new and established biologics to commercial scale, including antibody-drug conjugates, by translating technical knowledge into robust, compliant, and efficient manufacturing at pace across our global network.

You will focus on transfers of drug substances after approval while also crafting how new products are readied for scale-up and long-term manufacturability. Working across Global CMC, manufacturing sites, quality, regulatory and external partners, you will set strategy, drive execution, and embed digital ways of working that simplify complexity and accelerate delivery. How would you use your expertise in input processes, output procedures, and conjugation to de-risk transfers and strengthen supply resilience?

3. Accountabilities:

Post-Approval Tech Transfer Leadership: Lead end-to-end drug substance tech transfer activities across internal and external sites to meet Global CMC requirements, with a primary focus on post-approval biologics and ADCs, from planning through handover to commercial operations.

NPI Transfer Support: Represent the manufacturing operations perspective in cross-functional planning to ensure processes are scalable, transferable, inspection-ready, and suitable for reliable commercial manufacturing.

Technical Breadth Applied to Strategy: Use working knowledge of upstream, downstream, and conjugation to shape transfer strategy, conduct technical assessments, resolve issues, and implement changes across diverse biologic modalities.

Site and Capability Assessment: Evaluate internal and external site capabilities for process fit, equipment readiness, capacity, and compliance to determine suitability for transfer, scale-up, and lifecycle changes.

Operations Representation and Decision Influence: Embed practical manufacturing considerations into transfer strategies and execution plans by effectively representing Operations requirements with Global CMC and key stake-holders.

Cross-Functional Delivery: Partner closely with Manufacturing, MS&T, Quality, Regulatory, Supply Chain, Engineering, and external partners to define and deliver transfer plans aligned to business and supply priorities.

Compliance and Documentation: Ensure alignment with GMP operations and quality expectations, embedding inspection readiness and robust technical documentation into all transfer activities.

Risk Management and Problem Solving: Lead proactive risk identification, mitigation, and resolution for process, equipment, site, compliance, and supply risks across complex transfers.

Standardization and Continuous Improvement: Drive simplification and standardization of transfer practices, templates, and governance to improve speed, reliability, and knowledge capture across the network.

Digital Tech Transfer: Champion digital tools and data-led approaches to improve visibility, knowledge transfer, data quality, governance, and execution efficiency.

Matrix Leadership: Influence and build alignment across functions and partners without direct authority, ensuring timely decisions and high-quality execution.

4. Essential Skills/Experience:

Significant experience in CMC, production of drug substances, MSAT, or related biologics technical operations roles.

Familiarity with upstream, downstream, and conjugation processes combined with Tech transfer knowledge sufficient to support strategy, execution, and issue resolution across the biologic portfolio a plus

Experience supporting biologics portfolios with diverse modalities, including understanding of the different technical and operational considerations involved in transfer and commercialization.

Experience leading or supporting post-approval drug substance tech transfers, ideally including ADCs.

Experience supporting NPI tech transfers, with the ability to provide a strong Operations perspective to support reliable commercial manufacturing.

Strong understanding of internal and external manufacturing capabilities, including assessment of technical fit, site readiness, operational maturity, and transfer risk.

Good understanding of GMP operations, quality systems, and regulatory expectations relevant to biologics drug substance manufacturing and transfer.

Demonstrated ability to influence across a matrix organization, drive alignment, and deliver through collaboration across functions, sites, and external partners.

Strong leadership and communication skills, with the ability to engage technical teams, operational stake-holders, and senior leaders effectively.

Ability to challenge current approaches and reimagine ways of working, with interest in or experience using digital TT to improve delivery.

Strong problem-solving, risk management, and execution skills in challenging systems and administrative environments.

Bachelor’s, Master’s, or PhD in Biochemical Engineering, Chemical Engineering, Biotechnology, Biology, Pharmaceutical Sciences, or a related subject area.

Solid years of relevant experience in CMC matrix leadership, active pharmaceutical ingredient production, technical transfer, biologics process development, MS&T, or related pharmaceutical / biologics operations roles.

5. Desirable Skills/Experience:

• Direct experience transferring ADC conjugation processes and managing payload-specific considerations.
• Hands-on implementation of digital tech transfer platforms, data governance, and knowledge management tools at scale.
• Proven delivery of lifecycle changes and post-approval variations across internal and external manufacturing networks.
• Experience representing Operations requirements within Global CMC governance and with external partners.
• Advanced degree combined with equivalent experience focusing on biologics process development, scale-up, or manufacturing sciences.

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.

6. Why AstraZeneca:

Here, your expertise turns complex science into reliable supply for patients through tangible support and real investment in modern manufacturing. From smart, data-enabled sites to lean academies and digital transfer tools, we equip you to innovate while keeping quality and compliance at the core. You will work with unexpected teams in the same room to unlock faster scale-up and stronger robustness, all while contributing to our sustainability ambitions and a pipeline that spans new modalities. We value patience alongside ambition, pairing high standards with the mentorship, collaboration, and autonomy you need to leave a measurable impact on how medicines reach the world.

7. Call to Action:

If you are ready to lead the transfers that power our biologics portfolio and help patients sooner, take the next step 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.