[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.
