Biosimilar Analytical Development Lead

BioTalent; Slough; On-site; GBP 90,000 - 130,000; Full time

Job summary

BioTalent is seeking an experienced Group Leader, Analytical Development in London to provide technical leadership across a portfolio of monoclonal antibody biosimilar programmes. The role focuses on biosimilarity assessment, analytical strategy, and advanced molecule characterisation within a fast-growing R&D setting.

Note: this on-site position requires five days on-site. Visa sponsorship may be available for exceptional EU-based candidates.

Qualifications

• Strong experience in analytical development of biologics or biosimilars, ideally monoclonal antibodies.
• Expertise in analytical similarity assessment and molecule characterisation.
• Hands-on knowledge of HPLC platforms, CE techniques and mass spectrometry data interpretation.
• Experience supporting regulatory submissions and analytical CMC documentation.
• Proven ability to provide technical leadership and mentor scientific teams.
• Understanding PTMs and impurity profiling.

Responsibilities

• Lead analytical development activities for biosimilar mAb programmes.
• Drive biosimilarity and analytical similarity assessment strategies.
• Provide technical oversight of HPLC methods including CEX, SEC, Glycan, HIC and Protein A.
• Interpret LC-MS and advanced characterisation data.
• Support capillary electrophoresis techniques including cIEF and CE-SDS.
• Contribute to regulatory submissions and CMC documentation.
• Act as a subject matter expert in cross-functional project reviews.
• Mentor and develop analytical scientists.
• Identify and implement innovative analytical technologies and approaches.

Skills

Group leadership

Analytical development

Monoclonal antibodies

HPLC

Mass spectrometry

Regulatory submissions

Tools

HPLC platforms

Capillary electrophoresis

Mass spectrometry

Regulatory documentation tools

Job description

BioTalent is seeking an experienced Group Leader, Analytical Development in London to provide technical leadership across a portfolio of monoclonal antibody biosimilar programmes. The role focuses on biosimilarity assessment, analytical strategy, and advanced molecule characterisation within a fast-growing R&D setting.

Note: this on-site position requires five days on-site. Visa sponsorship may be available for exceptional EU-based candidates.