Senior Manager, Separation and Characterisation Sciences

Pharmaron Biologics

Liverpool

On-site

GBP 90,000 - 130,000

Full time

2 days ago
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Job summary

Pharmaron Biologics in Liverpool seeks a Senior Manager to lead the Separation and Characterisation Sciences team, shaping analytical CMC programmes and supporting GMP manufacture of biologics.

You will coach Senior Scientists, oversee mass spectrometry and peptide mapping, and guide method development, validation and technology transfer, while expanding the standalone analytical CRO offering and maintaining regulatory compliance.

Qualifications

  • A BSc, MSc or equivalent qualification in a relevant life sciences discipline.
  • Demonstrable expertise in biologics analytical development and product characterisation across modalities including antibodies and recombinant proteins.
  • Credible people-leadership experience with coaching and team development.

Responsibilities

  • Lead, coach and develop a team of scientists creating a culture of collaboration and excellence.
  • Provide direction in biologics analytical development, MS-based characterisation and chromatographic methods.
  • Oversee method development, validation, transfer to QC and regulatory documentation.
  • Engage with clients, support capability growth and drive operational excellence.

Skills

People leadership
Mass spectrometry
Peptide mapping
HPLC/UHPLC
Capillary electrophoresis
Analytical development
Regulatory submissions
GMP knowledge
Client engagement
Strategic leadership

Education

BSc or MSc in Life Sciences
Equivalent qualification

Tools

Mass spectrometry instruments
HPLC/UHPLC systems
Capillary electrophoresis

Job description

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.

What we are looking for

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 CapillaryElectrophoresis 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.

Desirable:

Experience within 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, inspections, operational excellence or technology-investment initiatives.

Why join us

Expand your expertise across a broad range of modalities, working alongside subject matter experts and contributing to innovative analytical approaches that support the development of advanced therapies, including ATMPs. Lead and shape a newly integrated scientific function, with the autonomy to develop capability, strengthen culture, and establish ways of working that drive scientific excellence. Play a key role in the growth of an evolving analytical CRO business, helping to define the future direction of our Separation and Characterisation Sciences services. Work on a diverse and exciting portfolio of biologics, gene therapy, and advanced therapy programmes, supporting multiple clients from development through to delivery. Combine scientific leadership, people development, client engagement, and strategic business contribution within a highly visible and influential role. Join a collaborative, high-performing autonomous team with strong technical foundations, where you will have the opportunity to make a tangible impact from day one.Access opportunities to learn, develop and grow within a global CRO/CDMO organisation.

Our Liverpool site

Our Liverpool facility provides integrated biologics development and manufacturing services across Analytical and Process Sciences. The site has an established track record in biologics development and offers capabilities supporting gene therapy drug substance development, viral vectors, plasmid DNA and analytical release and characterisation activities.At Pharmaron, we do more than manufacture batches. We develop medicines.

Job Introduction

Position: Senior Manager, Separation and Characterisation SciencesLocation: LiverpoolAbout PharmaronPharmaron is a global contract research and manufacturing organization (CRO/CDMO) helping pharma and biotech companies bring new therapies to life. With over 25,000 employees worldwide across 28 locations in the UK, US, China, and Singapore, we support drug discovery through to manufacturing with fully integrated high-quality services.We're proud of the impact we make and just last year, we supported 887 discovery projects, 1,100+ CMC programs, and 1,397 clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,300 global customers. To learn more, visit .We are seeking an experienced and people-focused Senior Manager to lead our newly combined Separation and Characterisation Sciences team in Liverpool. This is a key leadership opportunity for someone who can bring together

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