Associate Director, Drug Substance Tech Transfer Lead

AstraZeneca · Singapore

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Introduction to role

The role leads the drug substance technology transfer activities across the biologics portfolio, supporting Global CMC team deliverables and enabling robust, reliable commercial manufacturing across internal and external networks. The role has a particular focus on post-approval drug substance tech transfers, including ADCs, while also supporting NPI tech transfers by representing the Operations perspective to ensure successful scale-up, transfer readiness, and long-term manufacturability.

This role requires a strong solid understanding of upstream, downstream, and conjugation processes to support a biologics portfolio with diverse modalities. The individual will work across a complex matrix, partnering closely with Global CMC, Manufacturing, Quality, Regulatory, MSAT, and external partners to ensure tech transfers are accomplished in line with quality, supply, compliance, and business requirements. The role also calls for a forward-looking approach, with the ability to challenge current practices and help reimagine ways of working through digital tech transfer.

Accountabilities

• Lead drug substance tech transfer activities to deliver against Global CMC team requirements, with a primary focus on post-approval drug substance tech transfers across internal and external manufacturing sites.
• Lead post-approval DS tech transfers for biologics, including ADCs, ensuring robust planning, execution, risk management, and handover to commercial operations.
• Support NPI tech transfers by providing the Operations view into cross-functional planning and decision-making, helping ensure processes are scalable, transferable, and suitable for reliable commercial manufacturing.
• Apply working knowledge of upstream, downstream, and conjugation operations to support transfer strategy, technical assessments, issue resolution, and implementation across a portfolio of diverse biologic modalities.
• Assess internal and external site capabilities to determine suitability for process transfer, scale-up, and lifecycle changes, considering technical fit, equipment capability, facility readiness, capacity, and compliance requirements.
• Represent Operations requirements in discussions with Global CMC and other team members to ensure practical manufacturing considerations are embedded into transfer strategies and execution plans.
• Partner across functions including Manufacturing, MSAT, Quality, Regulatory, Supply Chain, Engineering, and external partners to define and complete transfer plans aligned to business and supply priorities.
• Ensure alignment with GMP operations and quality expectations, embedding compliance, inspection readiness, and robust technical documentation into all transfer activities.
• Lead risk identification, mitigation, and issue resolution across complex DS transfers, including process, equipment, site, compliance, and supply-related risks.
• Drive standardization, simplification, and continuous improvement in how drug substance tech transfers are planned and executed across the network.
• Demonstrate leadership in reimagining ways of working, including use of digital TT tools and approaches to improve visibility, knowledge transfer, data quality, governance, and execution efficiency.
• Influence decisions and lead in a matrix environment, building alignment across teams and stakeholders without direct formal authority over all contributors.

The ideal candidate is a technically credible and operationally minded leader with experience in biologics drug substance manufacturing and CMC. Technology transfer experience a plus. They bring enough technical breadth across upstream, downstream, and conjugation to operate effectively across a portfolio that includes diverse modalities, while also understanding the practical realities of manufacturing site readiness, transfer execution, and lifecycle management.

They are comfortable working across internal and external networks, influencing stakeholders at multiple levels, and ensuring Operations requirements are clearly represented in both strategic and day-to-day decisions. They are also motivated to simplify complexity and improve delivery through new digital ways of working.

Essential Skills/Experience:

• Bachelor’s, Master’s, or PhD in Biochemical Engineering, Chemical Engineering, Biotechnology, Biology, Pharmaceutical Sciences, or a related field.
• Significant experience in CMC, drug substance manufacturing, MSAT, or related biologics technical operations roles.
• Working knowledge of upstream, downstream, and conjugation processes and 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.
• trong leadership and communication skills, with the ability to engage technical teams, operational stakeholders, and senior leaders effectively.
• bility 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 complex technical and operational environments.

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 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.

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.

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