Senior Scientist/Scientist - Early Product Development

AstraZeneca Pharmaceuticals LP ,
Macclesfield, Cheshire
More Details

Overview

Job Description

Senior Scientist/Scientist - Early Product Development Macclesfield, UK Salary Competitive AstraZeneca is a global, science-driven biopharmaceutical company dedicated to discovering, developing, and delivering innovative, meaningful medicines and healthcare solutions that enrich the lives of patients. Pharmaceutical Sciences is a department within AstraZeneca R&D unit. The vision for Pharmaceutical Sciences is to deliver the therapies of the future through scientific leadership in drug delivery, design of synthetic routes and manufacturing of Active Pharmaceutical Ingredients (API) and drug product. Our portfolio of projects includes traditional small molecules, nucleotide based therapies and nanomedicines across AstraZeneca's therapy areas. We are looking for enthusiastic and highly capable Analytical Scientists to join our Early Product Development (EPD) team in Macclesfield, UK. Analytical Scientists within EPD work closely with formulation, biopharmaceutics and solid-state scientists in EPD to provide formulations for use in early clinical trials. You will work with scientists in other functions to drive science and innovation within drug projects; this will include collaboration with scientists at our Cambridge, Boston & Gothenburg sites. Main Duties and Responsibilities: + Development of robust analytical methodologies supporting project progression during the early development phase. + Interpreting analytical data and drawing reliable conclusions and recommendations to influence future work. + Identifying and solving potential analytical project issues. + Application of technical knowledge to improvement projects and the evaluation of new technology/processes. + Plan and conduct lab-based experimental work in accordance with project timelines. + Leading analytical development activities to support a single key project, or a number of smaller projects, during the clinical and commercial development phases, leading to the registration of new medicines + Authoring the CMC components of regulatory submissions and preparation of successful regulatory responses + The technical development of other scientists + Keeping a strong focus on quality for our patients + Working as a member of cross-functional teams, representing own department or area of expertise. + Ensuring that work is performed in accordance with appropriate Safety, Health & Environment (SHE), quality and compliance standards, e.g. Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP). + Publish novel work in peer reviewed journals Essential Skills and Capabilities: + A BSc, MSc, PhD or equivalent in Chemistry or Analytical Chemistry + Analytical chemistry knowledge (from content within degree course or relevant industrial experience). + Capability to develop skills and learn analytical techniques to support development activities. + Systematic approach to work, displays evidence of delivering to deadlines. + Applies a rational approach to problem solving; makes judgements based on sound reasoning, approaches problems in logical way. Desired Skills and Capabilities: + A proven record in a pharmaceutical or similar research/manufacturing industry + Pharmaceutical development project leadership, including analytical project planning and resource forecasting + Leading analytical requirement of manufacturing campaigns and managing analytical activities as contract manufacturing organisations + Scientific leadership skills, the ability to deliver robust scientific contributions to projects and demonstration of utilising risk based approaches for successful delivery + Knowledge of and practical experience of implementing control strategies (quality by design or equivalent) to define the requirements for ensuring the quality of drug substances + Experience of authoring CMC content for the analytical aspects of drug substance regulatory filings throughout the clinical development phase + Knowledge of and practical experience of quality and regulatory requirements (e.g. GMP and ICH), technology transfers and method validation + Knowledge of and practical experience in analytical method development across a range of techniques including LC, MS, GC, NMR + Experience of leading small groups of analysts and developing the technical abilities of other scientists + Excellent communication and stakeholder skills, and the ability to discuss complex ideas in a simple, easy to understand manner + Collaborative work ethic with experience of working internally and externally across a wide range of stakeholders and partners + Strong influencing and prioritisation skills Next Steps - Apply today! To be considered for this exciting opportunity, please complete the full application on our website. If you know someone who would be a great fit, please share this posting with them. Applications Open 24th December 19 Applications Close 23rd January 20

People also viewed