Group Leader Analytical Development

Accord Healthcare; Harrow; On-site; GBP 90,000 - 120,000; Full time

Benefits offered by this job

Holiday

Bonus

Pension scheme

Job summary

Accord Healthcare is seeking an Analytical Development Group Leader to head a team of analytical scientists in a biosimilars setting. You will lead method development, qualification, transfer, and analytical similarity activities, shaping strategy and ensuring Right First Time execution.

The role requires a PhD or MSc in biological sciences or analytical chemistry with extensive biosimilar experience and strong expertise in HPLC, LCMS, cIEF, CESDS. Drive innovation and regulatory readiness.

Qualifications

• PhD or Masters in biological science or analytical chemistry with extensive relevant work experience in biopharma/biotech 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)
• Understanding modification of biological molecules (PTMs)
• Experience with DOE tools and advanced data analysis packages
• Excellent understanding of analytical testing techniques such as HPLC, CESDS, cIEF, LCMS, CD

Responsibilities

• Lead and support Analytical development group for analytical method development, product characterization, method qualification, method transfer, Biosimilarity/analytical similarity activities
• Set technical strategy and ensure execution for internal projects and external collaborations (CROs/partners)
• Provide technical oversight during process troubleshooting and instrument challenges
• Ensure experimental plans, analyses and reports are scientifically sound and regulatory compliant
• Interface with Regulatory Affairs and support EMA/MHRA/FDA discussions
• Develop/mentor a high-performing analytical team and foster continuous improvement
• Identify and implement new technologies to enhance workflows
• Ensure GLP and EHS regulations are followed

Skills

Biosimilar development experience

Analytical method development

DOE methods

Data analysis

Education

PhD or MSc in biology/chemistry

Tools

HPLC

CESDS

cIEF

LCMS

CD

Job description

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.