Senior Director, CMC Product Lead and Biologics Technology Transfer – Global Operations

What happens in the critical moment when a breakthrough medicine leaves the lab and must reach patients around the world, flawlessly and at speed? In this role, you hold the answer, and the chance to reshape how AstraZeneca turns science into supply.

Your role

The Senior Director, CMC Product Lead and Biologics Process Technology Transfer is a dual-accountability leadership role within Global Technical Operations (GTO). You will lead complex Global CMC programs and Operations Global CMC teams, while also providing leadership for the GTO Biologics Technology Transfer organization, shaping its ways of working, organizational design, capabilities, governance, and talent to enable successful and sustainable technology transfer across the global network.

As an empowered Operations leader, you provide commercialization leadership from PPQ through lifecycle management and drive right-first-time, rapid and robust technology transfer across internal and external manufacturing networks to support Global CMC team priorities and timelines. Success depends on exceptional matrix and influence leadership, visible change leadership, and the digital awareness and learning agility to champion data-driven ways of working and AI-enabled capabilities.

Accountabilities

• Lead Operations Global CMC teams for complex biologics and other advanced modalities, with end-to-end accountability from development and PPQ through commercialization and lifecycle management.
• Define and drive integrated CMC strategies that ensure operational readiness, regulatory alignment and reliable market supply, managing risk and enabling timely decisions.
• Lead and develop the GTO Biologics Technology Transfer organization, including operating model, governance, capabilities and talent strategy.
• Implement business processes for right-first-time, rapid and robust transfers, driving standardization, clear roles, governance, risk management and continuous improvement.
• Drive network technology transfer deliverables in line with Operations priorities and commercialization timelines, and represent the network in Operations-wide initiatives.
• Partner with sites, MSAT, Development, Drug Product, Analytical, Quality and Regulatory to implement scalable good practices, align technical decisions and raise network maturity to best-in-class levels.
• Assess new and changing regulatory requirements and reflect them proactively in practices, governance and standards.
• Provide scientific leadership, remove barriers, drive simplification and champion digital tools, advanced analytics and AI-enabled capabilities across GTO.
• Own succession planning and capability building, and build a diverse, inclusive, high-performing organization.

Essential Requirements

• Substantial biopharmaceutical leadership experience, with deep expertise in biologics, commercialization and CMC leadership. Technology transfer experience is a plus.
• Proven track record of leading global technology transfer programs across internal and external manufacturing networks, including biologics and complex modalities.
• Experience leading Operations Global CMC teams, complex Global CMC programs or major biologics products across multiple technical functions.
• Strong scientific and technical credibility in biologics transfer, scale-up, process validation, PPQ, comparability and lifecycle management, with solid knowledge of global regulatory expectations (CMC, GMP).
• Significant experience in organizational development, succession planning and talent development, with exceptional matrix and influence leadership in a global environment.
• A degree in a relevant scientific or engineering discipline; an advanced degree is preferred.

Desirable Requirements

• Experience across both internal and external manufacturing networks, and in late-stage development, PPQ, commercialization and post-approval lifecycle management for biologics or complex modalities.
• Exposure to digital transformation, advanced analytics or automation in manufacturing, CMC, MSAT or technology transfer, and learning agility towards AI-enabled capabilities.
• Strategic and organizational leadership that connects technology transfer, commercialization and CMC priorities to business objectives and leads through complexity and change.
• An ownership-driven execution mindset, with a strong commitment to talent development, inclusion and high performance.

We will accept applications from candidates both in Södertälje, Sweden and Gaithersburg, US.

Why AstraZeneca

We're driven by our commitment to deliver accelerated growth and to make people's lives better. We're always working towards our ambition to deliver more medicines to patients quicker and more affordably. If you have the passion and the aim to accelerate growth and make people's lives better, then this is the place for you

What’s next

Lead the transfers that keep medicines on shelves and launches on time—send your CV to drive the next wave of digital, data-driven tech transfer excellence.

Welcome with your application, no later than 25th of November.

Date Posted

Closing Date