Senior Scientist - Oligonucleotide and Peptides analytics, Pharmaceutical Sciences

AstraZeneca ,
Macclesfield, Cheshire
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Senior Scientist - Oligonucleotide and Peptides analytics, Pharmaceutical Sciences (PS)/Pharmaceutical Technology and Development (PT&D) Salary: Competitive Location: Macclesfield 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 a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives and are made to feel valued, energised and rewarded for their ideas and creativity. Pharmaceutical Sciences Pharmaceutical Sciences is a department within our BioPharmaceuticals R&D organisation. The vision for Pharmaceutical Sciences is to deliver the therapies of the future through scientific leadership in drug delivery, synthetic route design and manufacturing of Active Pharmaceutical Ingredients (API) and formulated products. Our portfolio of projects includes a broad range of small and large synthetic molecules, from different drug modality classes, utilised in treatments across AstraZeneca's therapy areas. Pharmaceutical Technology and Development Pharmaceutical Technology and Development (PT&D) are the bridge, which turns brilliant science into actual 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. New Modalities are a key area for AstraZeneca, covering projects that are not standard small molecules. New Modalities include (but are not limited to) Peptides, Oligonucleotides, Antibody Drug Conjugates, Dendrimer Drug Conjugates, Polymer Drug Conjugates and Vaccine Adjuvants. This is an emerging field and is expected to change and grow in the near and long-term future. We are currently recruiting for - Senior Scientists with experience in the areas of oligonucleotide and peptide analysis to join our analytical group within our Chemical Development functions in PS and PT&D who are dedicated to the development of active pharmaceutical ingredients (API) at AstraZeneca across a range of small and large molecules. Typical responsibilities include: * Helping to shape analytical oligonucleotide and peptide strategy in collaboration with key stakeholders within and external to the function. * To lead API analytical activities to support project progression during the early pre-clinical and clinical development phases, through to late development and commercialisation * To demonstrate scientific leadership and strategic development of drug projects. * Planning and conducting lab-based experimental work in accordance with project timelines * To understand the external regulatory environment for New Modalities and support the development of AstraZeneca's regulatory strategy * To 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. * Identifying and solving potential issues as part of process development and clinical manufacturing. All these activities will have a significant impact on the speed, quality and cost of the AstraZeneca clinical portfolio. Qualifications, Knowledge and Experience * 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 oligonucleotide and/or peptide modalities. * An understanding of key analytical techniques for the analysis and characterisation of oligonucleotide and peptide modalities, especially chromatography and mass spectrometry. * A good understanding of the overall drug development process from discovery through to launch. * Experience in oligonucleotide/peptide analytical measurement science and control strategies. * Experience of leading technical contribution of a scientific program, both independently and alongside partners. * An understanding of the principles and management of SHE and cGMP. Skills and capabilities * Ability to think and operate across functional boundaries, challenge the status quo and seek opportunities for business improvement. * Experience of delivering CMC content or contributions, based on analytical activities, to regulatory filings for pharmaceutical products within the clinical development and commercialisation phase * Good problem solving skills. * Strong influencing and prioritisation skills to ensure project delivery to deadlines * Experience of supporting clinical manufacture and working with contract manufacturing organisations. Please

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