Analytical Development Group Leader
2 days ago
Harrow
Our client is a global life science organisation specialising in the latest development and manufacture of biopharmaceutical products across the world. At present, they are seeking a talented Group Leader within Analytical Development on a permanent basis at their facility in Middlesex. • Lead and support Analytical development group for analytical method development, product characterization, method qualification, method transfer, Biosimilarity/analytical similarity related activities, • Set technical strategy and ensure correct execution for internal projects and external collaborations (CROs /strategic analytical partners). Build 'RFT' (Right First Time) approaches/ culture within the analytical function., • Provide technical oversight during process - troubleshooting, addressing technical and instrumental challenges for smooth analytical operations, • Ensure experimental plans, analysis, and reports are scientifically sound, in line with current regulatory guidance and quality expectations., • Support team with logistics and planning., • Act as the analytical subject matter expert (SME) in cross-functional technical reviews, stage gate reviews, and partner discussions., • Support R&D leadership/scientific project leaders with clear strategy and regular status updates, • Support R&D leadership with analytical group budgetary requirements, • Develop/mentor a high-performing analytical team; foster a culture of scientific excellence, accountability, and continuous improvement., • Identify and implement new technologies (e.g., AAT, automation, digital platforms) to enhance analytical development workflows/ product advanced characterization, • Ensure GLP and EHS regulations are followed., • Propose new ideas/new concepts targeting robust analytical package for various regulatory submissions., • Support authoring and review of CMC sections of regulatory submissions (IND, IMPD, BLA, MAA), particularly Module 3 related to analytical development., • Interface with Regulatory Affairs to respond to regulatory queries and support interactions with EMA, MHRA, and FDA, • Strong scientific understanding of therapeutic proteins, monoclonal antibodies, fusion proteins and other recombinant biologic products., • Biosimilar development experience is essential, • Good experience and understanding of biologics analytical techniques/ methodologies such as HPLC, CESDS, cIEF, LCMS, CD etc, • Experience in statistical analysis, analytical equipment/ software troubleshooting capabilities, • Excellent leadership, communication, and stakeholder management skills., • Collaborate with teams across Upstream, Downstream, Quality, Regulatory, and Project Management functions., • Strong interpersonal skills with the ability to lead, build and motivate teams, • Strong organization skills, able to manage conflicting tasks to meet deadlines and to solve problems on your feet, even in a busy and changeable work environment, • PhD in biological science or analytical chemistry. Working experience in Biosimilar development is desirable., • Scientific background in biological product characterization, impurity identification and characterization, • Understanding biologic product characteristics (E.g. monoclonal antibodies, fusion proteins. Therapeutic proteins etc.), • Understanding of modification of biological molecules (PTMs, etc.), • Experience with DOE (Design of Experiment) tools and advanced data analysis packages, • Excellent understanding of analytical testing techniques such as HPLC, CESDS, cIEF, LCMS, CD etc, • Prior experience in analytical similarity/ Biosimilarity assessment, • Collaborative, enthusiastic, self-driven, and problem-solving skills are assets, • Software proficiency in Microsoft Office Suite (Excel, PowerPoint, Project, Word) #J-18808-Ljbffr