Senior Biosimilar Analytical Development Lead

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

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.