Director, Product Analytical Support - Operations
At AstraZenecawe work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.
As the Director, Product Analytical Support, you will provide overall scientific and strategic leadership for AstraZeneca analytical operations within Biologics. This is a managerial position with direct reports
- Accountable for all analytical activities supporting new product introduction (NPI) and global support for commercial products.
- Responsible for analytical readiness for process validation/PPQ campaign (drug product and drug substance) for late stage pipeline products
- Accountable for analytical method transfer from AstraZeneca’s Biopharmaceutical Development to commercial manufacturing sites within AZ Biologics operations as well as outside testing laboratories.
- Responsible for establishing and ensuring harmonized processes and best practice across products relating to various global analytical activities within biologics
- Responsible for ensuring harmonized compliance to internal standards and policies related to analytical operations across all biologics manufacturing sites.
- Responsible for ensuring Technical support for new business opportunity, due diligence and direct technical support as needed at the site level in a consulting or SME role.
- Responsible for establishing productive collaborations between R&D, Operations and the third-party suppliers to progress the projects
- Author/Review technical documents in the subject matter for regulatory submissions as needed
- Provide input and review for regulatory filings to ensure consistency in depth of content and strategic approach
- Responsible for bringing the external environment into AstraZeneca, e.g. benchmarking and provide forward thinking in anticipation of future needs
- MS in Biological Sciences or analytical chemistry
- 15-20 years relevant experience with a MS
- Requires experience in commercializing and supporting commercial biotherapeutics
- PhD with 12+ years relevant experience
Next Steps – Apply today!
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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 authorisation and employment eligibility verification requirements.