Group Leader Analytical Development

Group Leader Analytical Development Role: Full-time, permanent Location: Harrow, West London Salary: Competitive + bonus + benefits The Role: The Analytical Development Group Leader will be responsible for leading a team of Analytical Scientist and Team Leader within a Biosimilars environment.

• 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 The Person:
• PhD or Masters of biological science or analytical chemistry with extensive relevant work experience in biopharma/biotech research labs.
• Working experience in Biosimilar development is essential
• 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 The Rewards: In return, we offer a competitive salary and rewards package (including holiday, bonus and pension scheme). Not to mention the opportunity to genuinely make a difference in a new and dynamic role within a progressive and expanding business, at an exciting time of growing international reach. How to Apply: If you possess the experience, passion and ability to make this role a success then we would like to hear from you. Please complete your Candidate Profile on our careers site to apply for this role. For more information, you can contact us on: careers@accord-healthcare.com