Introduction

The Associate Director, Drug Substance Tech Transfer Lead provides technical and operational leadership for drug substance technology transfers across the biologics portfolio. The role focuses primarily on post-approval transfers, including ADCs, while supporting NPI transfers by representing Operations requirements and enabling scalable, robust, and reliable commercial manufacturing across internal and external networks.

The incumbent applies broad knowledge of upstream, downstream, and conjugation processes to shape transfer strategy, assess site readiness, manage technical and supply risks, and ensure GMP-compliant execution. Working across Global CMC, Manufacturing, Quality, Regulatory, MS&T, Supply Chain, Engineering, and external partners, the role also advances standardized and digitally enabled approaches to technology transfer.

Main Duties and Responsibilities

• Lead end-to-end post-approval drug substance technology transfers across internal and external manufacturing sites, including biologics and ADCs, from strategy and planning through execution, qualification, and handover to commercial operations.
• Support NPI transfers by representing the Operations perspective in cross-functional decisions and ensuring processes are scalable, transferable, and suitable for routine commercial manufacturing.
• Apply upstream, downstream, and conjugation expertise to define transfer strategies, conduct technical assessments, resolve issues, and support implementation across diverse biologic modalities.
• Assess site capability and readiness, including technical fit, equipment and facility suitability, capacity, operational maturity, compliance, and lifecycle requirements.
• Develop integrated transfer plans with Manufacturing, MS&T, Quality, Regulatory, Supply Chain, Engineering, Global CMC, and external partners, aligned with business and supply priorities.
• Embed GMP, inspection readiness, knowledge management, and complete technical documentation throughout transfer planning and execution.
• Lead identification, mitigation, escalation, and resolution of process, equipment, site, quality, compliance, timeline, and supply risks.
• Drive standardization, simplification, and digital technology transfer approaches that improve data quality, governance, knowledge transfer, visibility, and execution efficiency.
• Influence decisions and build alignment across a complex matrix without relying on direct authority.

Key Accountabilities

Accountable for:

• transfer strategies and executable plans that meet Global CMC, quality, regulatory, supply, and business requirements.
• safe, compliant, on-time delivery of post-approval and assigned NPI drug substance transfers, including effective qualification and operational handover.
• evidence-based site selection and readiness assessments, with material capability gaps and risks identified early and mitigated.
• robust process knowledge transfer, technical documentation, governance, and decision quality across internal and external partners.
• timely escalation and resolution of technical, compliance, schedule, and supply risks that could affect transfer outcomes or commercial continuity.
• measurable improvement in transfer consistency and efficiency through standardization, simplification, lessons learned, and digital TT capabilities.

Candidate Profile

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 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.

Required Experience and Capabilities

• Significant experience in CMC, drug substance manufacturing, MS&T, or related biologics technical operations roles.
• Solid understanding 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.
• Agility 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 partners, and senior leaders effectively.
• Able 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.

Education and Experience

• Bachelor’s, Master’s, or PhD in Biochemical Engineering, Chemical Engineering, Biotechnology, Biology, Pharmaceutical Sciences, or a related field.
• Solid years of relevant experience in CMC matrix leadership, drug substance manufacturing, technical transfer, biologics process development, MS&T, or related pharmaceutical / biologics operations roles.

Leadership Expectations

The role is expected to operate as a trusted technical and operational leader who can translate Global CMC requirements into effective transfer strategies and executable plans. The role requires strong judgment, resilience, and the agility to influence complex stakeholder groups while balancing technical, quality, supply, and business priorities. Success in this role will depend on the agility to represent Operations effectively, build alignment across a broad matrix, lead high-quality transfer execution, and continuously improve the way drug substance tech transfer is delivered.

Why AstraZeneca:

Here, your expertise turns 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 teams to unlock faster scale-up and stronger adaptability, all while contributing to our sustainability ambitions and a pipeline that spans new modalities. We value grit alongside ambition, pairing high standards with the mentorship, collaboration, and autonomy you need to leave a positive 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.