Associate Director, Chemical Development

This job has now expired please search on the home page to find live IT Jobs.

Associate Director, Analytical DevelopmentI am currently working with an exciting Pharmaceutical company who are Head Quartered in the US with operations in the UK.A remote-based position, as Associate Director, you will report to Programme Director for Analytical Development.This position will be responsible for managing the analytical strategies for pharmaceutical products in support of pre-clinical and early stage clinical development. Key Responsibilities:Oversee the development, qualification, validation and transfer of analytical test methods for drug substance (API) and drug product (DP) at contract laboratories.Plan and implement analytical testing strategies for small molecule drug substance and drug product development.Critically review data from contract partners, provide timely feedback to secure prompt resolution of technical and quality findings.Support characterisation of new chemical entities and reference standards.Work closely with colleagues in Research, CMC, Manufacturing and QA to establish specifications for drug substance and drug product.Collaborate with QA to ensure timely release of clinical trial supplies.Author and review analytical sections of regulatory submissions.Serve as a subject matter expert on multiple projects, author and review technical reports, memos, change control documents, deviation and investigation reports to capture development efforts, rationales and justifications of decisions.Key Requirements:Master of Science degree in analytical chemistry.At least 10 years' experience in analytical methods development supporting small molecules in the pharmaceutical, biotechnology or related industryStrong background in analytical development, stability study design and management, as well as expertise in cGMPs, ICH, USP, EP and other relevant regulatory requirements.Experience in authoring analytical sections of regulatory submissionsProven expertise in working on multiple programs simultaneously.If this remote-based Associate Director of Analytical Development looks like it could be the next step in your career, please don't hesitate to reach out as soon as possible! To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales