Senior Scientist - Oligonucleotide and Peptides analytics, New Modalities and Parenteral Developm...

AstraZeneca ,
Macclesfield, Cheshire
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Senior Scientist - Oligonucleotide and Peptides analytics, New Modalities and Parenteral Development (NMPD)/Pharmaceutical Technology and Development (PT&D) Location: Macclesfield, UK. AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceutical and the supply of healthcare services. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we 're proud to have an outstanding workplace culture that encourages innovation and collaboration. Here, employees are empowered to express different perspectives and are made to feel valued, energised and rewarded for their ideas and creativity. In Pharmaceutical Technology and Development (PT&D), we are the link between forward-thinking science and innovative medicines that help millions of people. We work across the entire value chain, crafting 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 a lead analytical pharmaceutical development scientist in New Modalities and Parenteral Development (NMPD) with significant scientific project-based experience. 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 projects that are not standard small molecules. New Modalities can include Peptides, Oligonucleotides, Antibody Drug Conjugates, Dendrimer Drug Conjugates, Polymer Drug Conjugates and Vaccine Adjuvants. This is an exciting new field and is encouraged to change and grow in the near and long-term future. In NMPD, you will join a vibrant team that is working on the next generation of medicines and play a key role in the analytical development of new medicinal products. We are looking for a senior scientist with experience in the areas of oligonucleotide and peptide analysis. You will bring a strong analytical perspective to the team across a diverse, multi-skilled area and be an authority in the late stage development of drug products. 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. With a global company that believes in helping its people both personally and expertly, this is your opportunity to deliver medicines that have a direct impact on patients' lives. As an Analytical Senior Scientist in NMPD your main responsibilities will involve the following, all of which have a significant impact on the speed, quality and cost of the AstraZeneca clinical portfolio: Craft analytical oligonucleotide and peptide strategy in collaboration with key partners within and external to the function. 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. Identify and seek analytical project issues and risk management. Qualifications, Knowledge and Experience * BSc, MSc or equivalent in a relevant subject area with a consistent track record in the pharmaceutical environment or a PhD with significant experience, working with oligonucleotide and/or peptide modalities. * An understanding of key analytical techniques for the analysis and characterisation of large molecules (ideally oligonucleotide and peptide modalities), especially chromatography and mass spectrometry. * Experience of characterising and developing analytical methods for large molecules. * Experience in oligonucleotide/peptide analytical measurement science and control strategies * An understanding of the overall drug development process from discovery through to launch * You will lead technical and contri

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