Analytical Development Group Leader

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)