Senior Analytical Scientist (Method Development & Platform Innovation) – Contract position

[What the role is]

To lead the development, optimization, and validation of bioassays and advanced analytical methodologies to support the regulatory testing of monoclonal antibodies (mAbs) and next-generation formats (ADCs, bispecifics, scFvs, AOCs etc.) to ensure the quality and safety of innovator and biosimilar products in the market.

[What you will be working on]

Technical Excellence & Method Development:

• Lead bioassay development for monoclonal antibodies and next-generation complex formats (ADCs, bispecifics, scFvs, AOCs etc.) that reflect functionality including ADCC/CDC assays, dual-target engagement, payload-mediated cytotoxicity, and chain-pairing analysis.
• Develop and validate analytical methods using advanced techniques including Surface Plasmon Resonance (SPR) and Biolayer Interferometry (BLI) for complex binding interactions and High-Resolution Mass Spectrometry (HRMS) for structural characterisation, Drug-to-Antibody Ratio (DAR) determination and conjugation site analysis.
• Establish platform capabilities for physicochemical characterisation including peptide mapping, glycan profiling, post-translational modification analysis, charge variant assessment, and conjugate characterisation that can be applied across different biologics classes.
• Drive method transfers from research laboratories to regulatory testing facilities, ensuring robust validation according to ICH Q2(R1/R2) and relevant guidelines.
• Support laboratory transformation initiatives including integrating AI and automation tools to enhance productivity, identifying capability gaps for emerging biologics formats, and proposing actionable improvement plans for next-generation testing requirements.

Consultancy & Leadership

• Provide expert scientific opinions related to biologics testing to clients and stakeholders.
• Evaluate training programs and provide technical guidance to the team to enhance lab testing capability.
• Represent the laboratory to present the research and development findings at local and international conferences, meetings and professional forums.

Quality & Safety

• Prepare comprehensive validation reports and technical documentation to support method implementation in the laboratory.
• Support laboratory accreditation activities according to ISO17025 standards.
• Assist in administrative tasks to ensure smooth laboratory operations.

[What we are looking for]

Education & Experience:

• Strong background in Life Sciences, Biomedical Sciences, Biochemistry, or relevant scientific disciplines.
• Minimum 7 years of laboratory experience for biologics testing and method validation.
• Experience with characterisation and bioassay development for monoclonal antibodies or next-generation complex formats (ADCs, bispecifics, scFvs, AOCs etc.) preferred.

Technical Skills:

• Hands-on experience with cell-based bioassays, particularly proliferation assays, reporter gene systems, ADCC/CDC effector function and cytotoxicity assays.
• Proficiency in Biolayer Interferometry (BLI) or Surface Plasmon Resonance (SPR) for binding kinetics assays.
• Experience with chromatographic techniques (SEC-HPLC, CEX-HPLC, HIC-HPLC) for biologics quality assessment.
• Working knowledge of LC-MS techniques for protein characterisation, including intact mass, peptide mapping, glycan and PTM analysis.
• Familiarity with statistical software (GraphPad Prism, R, or similar) for bioassay data analysis and parallel line analysis.

Regulatory & Quality Knowledge:

• Understanding of ICH guidelines for biologics and method validation principles.
• Knowledge of biosimilar regulatory requirements and comparability studies preferred.
• Experience with ISO/GLP/GMP laboratory practices preferred.

Soft skills:

• Strong project management abilities with experience coordinating multi-site collaborations.
• Excellent communication skills for technical reporting and stakeholder engagement.
• Ability to work independently while contributing effectively to cross-functional teams.
• Problem-solving mindset with attention to detail in experimental design and data interpretation.