Jobs / Sweden / Astrazeneca Pharmaceuticals Lp

Astrazeneca Pharmaceuticals Lp

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

Sweden - Gärtuna Posted today

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LeadershipComplianceRisk management

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About the role

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

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