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.
Job responsibilities:
* 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
Core Skills:
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
Qualifications & Experience:
* 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)
Salary description
£75000.00 - £80000.00 per year