Associate Director, Drug Product Technology Transfer CMC – Global Technical Operations

We are looking for an Associate Director, Drug Product Technology Transfer! Ready to lead the transfer processes, between sites and into commercial production? Excellent, then welcome to us at AstraZeneca.

In this role, you will help ensure that medicines can be manufactured safely, reliably and at the right quality, whether production is moving between internal sites, to an external manufacturing partner, or from development into commercial manufacturing.

Your main focus will be post-approval tech transfers, while also supporting the introduction of new products into commercial production. You will represent the needs of Operations in multi-functional teams and work closely with colleagues in Global CMC, Manufacturing, Quality, Regulatory, MS&T, Engineering and external partners.

The role requires strong CMC leadership skills, technical knowledge of aseptic manufacturing and liquid filling, together with a practical understanding of technology transfer, validation and manufacturing site capabilities. You will also have the opportunity to improve and digitalise how tech transfer is planned and delivered across the organisation.

Your role and accountabilities

In this role, you will:

• Lead tech transfer projects for drug products.
• Support new product introductions by ensuring that manufacturing requirements are considered early and that products are suitable for reliable, large-scale production.
• Develop transfer strategies and plans for aseptic drug product manufacturing, including liquid filling and lyophilisation.
• Assess manufacturing sites to determine whether they have the right equipment, capabilities, capacity, technical maturity and operational readiness.
• Coordinate cross-functional teams and work with internal stakeholders and external manufacturing partners to deliver transfer activities.
• Lead validation activities, including equipment qualification, process performance and the implementation of manufacturing changes.
• Handle technical risks related to the process, equipment, site, compliance and supply.
• Ensure appropriate documentation is in place, including transfer plans, risk assessments, validation documentation and knowledge-transfer materials.
• Represent Operations in technical and strategic decision-making, ensuring that solutions are practical and sustainable for commercial manufacturing.
• Support the handover to commercial operations, making sure that the receiving site has the required knowledge, documentation, training and process understanding.
• Drive continuous improvement by simplifying processes, improving standards and strengthening governance across the tech transfer organisation. Advance use of digital tools, structured data and more efficient ways of working.
• As needed by business serve as the operations technical lead for early products

You will be expected to balance technical depth with practical delivery. Success in this role will depend on your ability to make sound decisions and influence colleagues across functions and organisational boundaries.

Essential requirements

To be successful in this role, you will have:

• Significant experience in CMC matrix leadership, drug product manufacturing, technical transfer, MS&T or a related technical operations discipline within the pharmaceutical industry.
• Strong knowledge of drug product tech transfer, including planning, documentation, risk management, comparability and execution oversight.
• Experience with post-approval transfers and an understanding of the associated quality, regulatory, supply and operational requirements.
• Experience supporting new product introductions and representing Operations requirements in cross-functional teams.
• Technical expertise in aseptic manufacturing, including contamination control, process controls and manufacturing execution.
• Strong knowledge of liquid filling and lyophilisation, including process understanding and manufacturing considerations relevant to transfer and scale-up.
• A sound understanding of validation, including equipment qualification, process validation, process performance and change implementation.
• Experience assessing manufacturing site capabilities, including technical fit, readiness, compliance and transfer risk.
• Strong communication and influencing skills, with the ability to work effectively with technical, operational and senior partners.
• The ability to lead through influence, align teams and deliver results without relying on direct line management.
• A Bachelor’s, Master’s or PhD in Pharmaceutical Sciences, Chemical Engineering, Biochemical Engineering, Chemistry, Life Sciences or a related field.
• 5–10 years of relevant experience in drug product manufacturing, technical transfer, MS&T, aseptic processing or related pharmaceutical development and supply roles.

Desirable requirements

It would be advantageous if you also have experience working across internal manufacturing sites, external partners, and contract manufacturing organisations, with a strong understanding of lifecycle management and post-approval changes in commercial manufacturing environments. Experience driving or supporting digital tech transfer, knowledge-transfer tools, or other digital solutions within technical operations is also valued. We are looking for someone who has successfully collaborated across development, manufacturing, quality, regulatory, and engineering functions, and who has contributed to improving, standardising, or simplifying tech transfer processes across sites or business areas. An ability to challenge established ways of working and identify more efficient, effective approaches is essential.

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 15th of November. Interviews will be held continuously so don’t hesitate to apply!

Date Posted

Closing Date