Associate Principal Scientist - Process Chemistry

AstraZeneca Pharmaceuticals LP ,
Macclesfield, Cheshire
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Job Description

Associate Principal Scientist - Process Chemistry AstraZeneca is a global, innovation-driven biopharmaceutical company where we not only focus on the discovery, development and delivery of life-saving medicines to our patients but believe in sustainability and are determined to minimise the impact of our work on the environment. We are proud to be a great place to work and have a culture that inspires 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 aim 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 now have exciting opportunity for an Associate Principal Scientist in our growing process chemistry teams. The responsibilities and requirements of the position are outlined below. As an expert process chemist with a consistent track record of delivering pharmaceutical development projects, you will be responsible for leading small groups of development scientists and the technical and regulatory contribution to API delivery. The role holder will provide process chemistry leadership into pharmaceutical development delivery teams, develop process chemists and deliver the Chemistry, Manufacturing and Control (CMC) aspects for projects to meet development timelines. You will work collaboratively with analysts, engineers, project managers, quality assurance and external partners to achieve success. The role encompasses some or all of the following key drivers, depending on the stage of clinical development: speed, quality, cost, efficiency, measurement, control strategy, robustness and understanding, to ensure quality of API and knowledge of processes for toxicology trials, clinical evaluation and commercialisation. Key responsibilities include: + To lead complex development projects, or a portfolio of projects, from phase 2b/3 to commercial within the process chemistry skill area and to drive cross-functional collaboration + To provide expert challenge to drug projects and role model positive behaviours in exploring new ways of working and scientific development, incorporating external perspectives + To provide scientific/technical leadership across the skill groups in resolving risks, identifying learning to share across the department and deliver regulatory submissions + To demonstrate scientific leadership and strategic development of drug projects, representing Chemical Development on CMC Project and Global Supply Teams. + To deliver CMC content or contributions to regulatory filings throughout the clinical development phase and commercial filings and preparation of successful responses to questions, applying sound knowledge of regulatory guidelines (e.g., ICH, EMA, FDA) and other territorial requirements. + Mentoring and developing colleagues, supporting them in reaching their full potential. + Identifying and solving potential issues and acting as an interface between departments. + Contributing to improving the capability of Chemical Development to support the current and future project portfolio, defining and delivering continuous improvement plans. + To act, as appropriate, as an authorised person accountable for the approval of documentation Profile: + BSc, MSc or PhD level education in a relevant organic chemistry discipline with a significant number of years' experience working within a Research & Development and Manufacturing environment, within the pharmaceutical industry. + An established scientific reputation, e.g. publications in peer-reviewed journals, patents, talks at international conferences, etc. + A good understanding of the overall drug development process from discovery through to launch. + Experience of technical supervision, coaching and mentoring, or leading small teams of people to deliver scientific projects. + A detailed understanding of the principles and management of SHE and cGMP. + Significant experience of delivering CMC content or contributions to regulatory filings throughout the life cycle of process development, in the pharmaceutical industry. + An understanding of key chemistry technologies used in the development and manufacture of API. Skills and capabilities + Ability to think and operate across functional boundaries, challenge the status quo and seek opportunities for business improvement! + Ability to analyse and interpret complex situations and provide clear strategi

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