About this role
[What the role is] To lead/support the development, optimisation and validation of bioassays and analytical methods for testing monoclonal antibodies (mAbs) and next-generation biologics, including antibody-drug conjugates (ADCs), bispecific antibodies, single-chain variable fragments (scFvs), and antibody-oligonucleotide conjugates (AOCs), to support quality and safety assessment. [What you will be working on] Technical Excellence & Method Development:
• Develop and validate bioassays such as ADCC/CDC activity and cytotoxicity assessment for monoclonal antibodies and advanced biologics, including ADCs, bispecific antibodies, scFvs, and AOCs. • Develop and validate analytical methods using SPR or BLI to assess complex binding interactions or using HRMS to support structural characterisation, drug-to-antibody ratio determination, and conjugation site analysis. • Lead or support the development of platform methods for physicochemical characterisation across biologics classes, including charge variant analysis, peptide mapping, glycan profiling and post-translational modification analysis. • Where applicable, lead or support the transfer of methods from research laboratories to regulatory testing facilities, ensuring robust validation in line with ICH Q2(R1/R2) and other relevant guidelines. • Support laboratory transformation by integrating AI and automation tools to improve productivity, address capability gaps in emerging biologics formats, and develop actionable plans for next-generation testing needs.
Quality & Safety
• Prepare comprehensive validation reports, standard operating procedures (SOPs), and technical documentation to support method implementation in the laboratory. • Support laboratory accreditation activities according to ISO 17025 standards, including supporting internal audits, maintaining quality documentation, and contributing to corrective and preventive action (CAPA) processes. • Assist in administrative tasks to ensure smooth laboratory operations.
Consultancy & Leadership (applicable only to senior role)
• Provide expert scientific opinions related to biologics testing to clients and stakeholders. • Evaluate training programmes and provide technical guidance to the team to enhance laboratory testing capability. • Represent the laboratory to present the research and development findings at local and international conferences, meetings and professional forums.
[What we are looking for] Education & Experience:
• PhD in Life Sciences, Biomedical Sciences, Biochemistry, or relevant scientific disciplines. • At least 3 years of post-PhD industry or research experience in biologics testing and analytical method validation.
Technical Skills:
• Hands-on experience in cell-based bioassays, including proliferation assays, reporter gene systems, ADCC/CDC effector-function assays, or cytotoxicity assays. • Experience in binding kinetics and interaction analysis using Biolayer Interferometry (BLI) or Surface Plasmon Resonance (SPR). • Experience in chromatographic techniques for biologics quality assessment, such as SEC-HPLC, CEX-HPLC, and HIC-HPLC. • Experience with LC-HRMS platforms for protein characterisation, including intact mass analysis, peptide mapping, glycan profiling, and post-translational modification analysis would be advantageous.
Regulatory & Quality Knowledge:
• Understanding of ICH guidelines relevant to biologics development, testing, and analytical method validation. • Familiarity with ISO 17025, GLP, or GMP laboratory environments is required. • Knowledge of biosimilar regulatory requirements, including comparability assessment principles, would be an advantage.
Soft skills:
• Excellent communication skills for technical reporting and stakeholder engagement. • Ability to work independently and exercise sound scientific judgement while contributing effectively to cross-functional teams. • Analytical mindset with meticulous attention to detail in experimental design, data interpretation, and documentation. • Strong project management abilities, with demonstrated experience coordinating multi-site or cross-functional collaborations (applicable only to senior role). The successful candidate will be offered a 1-year contract (with an option to extend for a further one year).