Senior Manager, Separation and Characterisation Sciences

two complementary scientific groups, build a cohesive and high-performing team, and shape the future direction of our biologics analytical capabilities.

You will provide scientific, technical and strategic leadership across analytical CMC programmes supporting the development, characterisation, transfer, validation and GMP manufacture of biologics and advanced therapies. The role combines team leadership with technical oversight, client engagement and the opportunity to expand our standalone analytical CRO offering alongside CDMO project delivery.

This position would suit an established scientific leader or a highly credible Principal Scientist or Group Leader who already has meaningful people-leadership experience and is ready to take on broader responsibility.

What you will doLead, coach and develop a team of Senior Scientists, Scientists and a Scientific Associate, creating a strong culture of collaboration, scientific excellence, accountability and continuous improvement. Bring

together the Separation Sciences and Characterisation teams, establishing clear priorities, effective ways of working and a shared team identity. Provide subject-matter expertise and technical direction in biologics analytical development and physicochemical and biophysical characterisation. Guide complex characterisation activities, with particular emphasis on mass spectrometry and peptide mapping, alongside chromatography-based methods such as HPLC/UHPLC, (reverse phase, SEC and IEX). Oversee method development, optimisation, phase-appropriate validation, method lifecycle management, comparability studies and technology transfer into QC for routine GMP release testing.

Review and approve protocols, reports, specifications, development strategies and relevant regulatory submission content. Lead or support analytical programmes, complex investigations, manufacturing support activities and cross-functional CMC discussions. Act as a technical partner to clients through project meetings,

capability presentations, proposal development, technical due diligence and issue escalation. Work with commercial and scientific colleagues to help develop the site's analytical CRO business and win standalone characterisation projects. Drive operational excellence, digitalisation, Lean and 5S initiatives, and contribute to technology and CAPEX planning. Support audits and inspections and ensure delivery in accordance with quality, regulatory, GMP and EHS requirements.

A BSc, MSc or equivalent qualification in a relevant life sciences discipline, with substantial biopharmaceutical experience.

Demonstrable expertise in biologics analytical development and product characterisation, for a range of biological modalities including but not limited to monoclonal antibodies, recombinant proteins. Understanding of mass spectrometry and peptide mapping techniques and experience of chromatography-based separation techniques such as HPLC/UHPLC and Capillary Electrophoresis is also expected. Credible people-leadership experience, ideally gained over at least three years, with evidence of coaching, performance management, team development and building effective scientific teams.

The ability to balance scientific depth with an engaging, collaborative and people-focused leadership style. Experience of method development, comparability assessment, reference standard qualification, method lifecycle management, analytical validation and/or technology transfer. Strong knowledge of GMP, Quality Management Systems and the requirements for transferring analytical methods into a regulated QC environment. Confident communication and stakeholder-management skills, with the ability to explain complex science clearly and influence decisions.

Strong problem-solving, prioritisation and decision-making skills, with the ability to lead through change.

Experience with in a client-facing biologics CDMO, CRO or biopharmaceutical environment. Experience leading client programmes, capability discussions, proposals or technical due diligence activities. Strong technical knowledge of mass spectrometry and peptide mapping. Knowledge of gene therapy or advanced therapy products. SME depth of knowledge in one or more physicochemical or biophysical characterisation techniques, such as mass spectrometry, icIEF, SEC-MALS, DLS, DSF or DSCExperience supporting analytical CMC strategies or regulatory submissions such as IND, CTA, BLA or MAA.

Experience supporting audits,…