Senior/Analytical Scientist (Method Development & Platform Innovation)

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. 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. 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…