Director of Drug Product Tech Transfer, GTO

at  AstraZeneca

Are you an experienced leader, with strong project management skills and great knowledge in tech transfer? Excellent, then use your strategic attitude to help us deliver medicine to patients worldwide – welcome to AstraZeneca!
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being ambitious, thinking big and working together to make the impossible a reality. Swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
Join our Biologics Global Technical Operations (GTO) team, where we work closely with AstraZeneca’s manufacturing network of internal sites and external manufacturing partners (CMOs), our colleagues in R&D, Quality, Regulatory, Supply Chain, and Commercial. We provide drug product technical leadership to ensure delivery of quality products to our patients and support our product pipeline.

Main task and accountabilities:

• Lead cross functional technology transfer teams with colleagues from Development, Quality/Regulatory, Supply Chain, Operations, and others to transfer biologic drug product and combination product processes from one commercial facility to another
• Support the transfer of products and processes from R&D labs into a commercial facility as a Receiving Unit SME
• Support preparation of regulatory submissions, technical support during inspections and audits, and respond to questions from regulatory bodies as the need arises
• Drive continuous improvements working with other Global Tech Ops functions to ensure robust, reliable, and compliant technology transfer, validation and commercial manufacturing processes using risk-based processes and Lean principles
• Lead and support initiatives toward standardization, digitalization and continuous improvement of business processes and ways of working in technology transfer and validatio

In this role, you will play a pivotal role in channeling our scientific capabilities and make a positive impact on changing patients’ lives. You will be recognized internally and externally as an authority in your area – an in-demand problem solver for key technical challenges. As a leader of technology transfer projects, you will work in cross-functional teams with colleagues from multiple different global functions and the manufacturing sites, both internal AZ and assigned CMO partners, to commercialize products and processes in time to deliver high-quality products to patients.
As a senior member of the Drug Product tech transfer team, you’ll lead and handle the projects and initiatives with the largest complexity. You set example, and mentor more junior tech transfer leads and SMEs to flourish.

Main task and accountabilities:

• Lead cross functional technology transfer teams with colleagues from Development, Quality/Regulatory, Supply Chain, Operations, and others to transfer biologic drug product and combination product processes from one commercial facility to another
• Support the transfer of products and processes from R&D labs into a commercial facility as a Receiving Unit SME
• Support preparation of regulatory submissions, technical support during inspections and audits, and respond to questions from regulatory bodies as the need arises
• Drive continuous improvements working with other Global Tech Ops functions to ensure robust, reliable, and compliant technology transfer, validation and commercial manufacturing processes using risk-based processes and Lean principles
• Lead and support initiatives toward standardization, digitalization and continuous improvement of business processes and ways of working in technology transfer and validation