Associate Principal Scientist - Particle isolation, drying and size reduction

AstraZeneca ,
Macclesfield, Cheshire

Overview

Job Description

Associate Principal Scientist - Particle isolation, drying and particle size reduction AstraZeneca is a global, innovation-driven biopharmaceutical company where we focus on the discovery, development and delivery of life-saving medicines to our patients coupled with a strong belief in sustainability, and a determination to minimise the impact of our work on the environment. We are proud to be a phenomenal place to work and have a culture that encourages innovation and collaboration. We empower our colleagues to express different perspectives and at the same time feel valued, respected and rewarded for their ideas and creativity. Chemical Development: In Chemical Development we believe that nothing is impossible, and we are determined to push the boundaries of science to deliver medicines to our patients. We combine people's technical knowledge and understanding with their talent and drive to design, develop and optimise synthetic routes that deliver the active pharmaceutical ingredients of our medicines in a sustainable, commercially viable way. We believe in innovation and continuous improvement, working closely with colleagues in academia and across industry, to ensure that we apply the newest technologies and principles in the processes we develop. We have an open position for an Associate Principle Scientist in isolation, drying and particle size reduction in our Process Engineering Team. The responsibilities and requirements of the position are outlined below. As an Associate Principle Scientist, you will be a scientific leader in your field and will drive a strategy to ensure right first time delivery of drug projects. Together with your colleagues in other skill areas you will plan and drive improvement projects that will vary from technical activities, use of new technologies or modifying our ways of working within AstraZeneca or externally with our Contract Manufacturing Organisations (CMOs). On development projects you will work closely with chemical engineers, chemists, analysts, and statisticians to design, develop, optimise and scale-up complex processes to robustly deliver drug substance with desired physicochemical attributes. Key responsibilities include: Providing expertise to development projects in drug substance filtration, drying and particle size reduction in terms of scale-up robustness and manufacturability. Acting as a scientific leader to initiate, drive and deliver science and technology improvement projects and other improvement activities in the area within and outside the Chemical Development department. Leading the isolation and drying technical working group (currently 5 process engineers). Developing external contacts and closely collaborating with our industrial and academic partners to bring learning and alternative process engineering science into AstraZeneca. Solving complex scientific problems. Developing knowledge in your field across the department. Contributing to the overall particle strategy, ensuring processes are fully understood and will robustly deliver consistent drug substance quality. Contributing to the delivery of CMC content and contributions to regulatory filings throughout the clinical development phase and commercial filings. Preparing successful responses to relevant questions, applying sound knowledge of regulatory guidelines (e.g., ICH, EMA, FDA) and other territorial requirements. Driving scientific excellence internally and externally by presenting current and novel approaches in the area at scientific conferences and authoring scientific publications Essential requirements: * A degree and / or PhD in Chemistry or Chemical Engineering, or related subject. * Significant experience working in the Pharmaceutical or Fine Chemicals Industry. * Expertise in 2 of filtration, drying or particle size reduction (including process development, process optimisation, scale-up and troubleshooting). Knowledge of key equipment in this area including centrifuges and different drying technology. * Knowledge of a broad range of particle/materials characterisation techniques (eg SEM, Morphologi, G3, Particle Size Distribution measurement) * Ability to use modelling software (e.g. Aspen, DynoChem, gPROMS FormulatedProducts, CFD, DEM) to support process understanding. * Experience working with internal and external partners including CMOs, vendors and academia * Ability to assess, review and report data from own work, with a clear understanding of its reliability. Interpret findings and draw authoritative conclusions and recommendations so that their significance can be appreciated. * Work as a member of multi-functional teams, with a large degree of independence representing own department or area of expertise. * Experience working with appropriate Safety, Health & Environment (SHE), quality and compliance standards, e.g. Good Manufacturing Practice (GMP) * Strong communication and influencing skills. Preferred Requirements: * Experience of the manufacturing of drug