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Do you have a passion for Science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
In Pharmaceutical Technology and Development (PT&D), we are the bridge between brilliant science and innovative medicines that help millions of people. We work across the entire value chain, designing and delivering active ingredients, formulations and devices required to support new medicines – from supplies for use in early toxicology studies and clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture.
We are currently looking for an Analytical Senior Scientist in Large Molecule characterization to strengthen our team and join us in New Modalities and Parenteral Development (NMPD) function.
Within NMPD our vision is to transform product design and development to enable us to deliver New Modality and Parenteral Medicines to Patients. New Modalities is a key area for AstraZeneca, covering synthetic large molecules. New Modalities can include mRNAs, Peptides, Oligonucleotides, Dendrimer Drug Conjugates and Polymer Drug Conjugates. This is an exciting new field and is expected to change and grow in the near and long-term future.
Main Duties & Responsibilities
You will be responsible for delivering analytical knowledge that encompasses understanding of manufacturing processes, control strategy and robustness. You will work cross functionally with multiple internal and external interfaces (Manufacturing, Chemical and Formulation Development, Regulatory CMC, Quality Assurance, Supply Chain and Contract Research Organisations), supporting drug projects from the early clinical phase through to commercial filings.
Your main responsibilities will involve the following:
- Develop analytical control strategies for new medicinal products within the New Modalities portfolio, leading to the registration of new medicines.
- Lead drug product analytical activities to support project progression during the clinical development phases through to commercialisation
- Demonstrate scientific leadership to facilitate strategic development of drug projects and technical development of other scientists;
- Plan and execute experimental work in accordance with project timelines
- Understand the external regulatory environment for New Modalities and support the development of AstraZeneca’s regulatory strategy
- Deliver CMC content or contributions to regulatory filings throughout the clinical development phase and preparation of successful query responses to questions, applying sound knowledge of regulatory guidelines (e.g., ICH, EMEA, FDA) and other territorial requirements.
- BSc, MSc or equivalent in a relevant discipline with a proven track record in the pharmaceutical environment or a PhD with significant experience, working with large molecules (e.g. mRNA, oligonucleotide or peptide modalities).
- A strong understanding of key analytical techniques for the analysis and characterisation of large molecules, especially chromatography and mass spectrometry.
- Experience of characterising and developing analytical methods for large molecules.
- Scientific leadership skills, the ability to deliver robust scientific contributions to projects and demonstration of utilising risk-based approaches for successful delivery.
- Good communication and stakeholder skills, and the ability to discuss complex ideas in a simple, easy to understand manner.
- Experience of authoring CMC content for the analytical aspects of drug product regulatory filings throughout the clinical development phase.
- An understanding of the principles and management of SHE and cGMP.
- Experience of technical supervision, coaching and mentoring or leading small teams of people or scientific projects.
- Effective influencing and prioritisation skills to ensure project delivery to deadlines.
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together.