Principal Scientist II - Immunoassay Bioanalysis (PK/ADA/PD)

We are seeking a Principal Scientist II to act as a subject matter expert across immunoassay based bioanalytical programmes supporting pharmacokinetic (PK), anti drug antibody (ADA), and pharmacodynamic (PD) studies. This role provides scientific leadership across multiple studies, focusing on complex assay troubleshooting, assay strategy, scientific oversight, and client engagement. The successful candidate will be recognised as a technical expert in ligand binding assays and will support the development, optimisation, validation, and long term scientific robustness of immunoassay platforms and methodologies across a range of therapeutic modalities.

• Provide scientific leadership and SME support across immunoassay bioanalytical studies supporting PK, ADA, and PD endpoints
• Lead troubleshooting of complex assay challenges, including drug interference, matrix effects, non specific binding, assay variability, and sensitivity limitations
• Advise on assay design, optimisation, and validation strategies, ensuring assays are scientifically sound and fit for purpose
• Support study teams in resolving technical issues and ensuring consistent assay performance across programmes
• Provide scientific oversight for complex or high profile studies and contribute to assay strategy discussions
• Contribute to client interactions, including scientific discussions, assay justification, data interpretation, and issue resolution
• Support proposals, bid defences, and scientific strategy discussions
• Mentor and support development of laboratory scientists and junior scientific staff
• Contribute to continuous improvement initiatives and development of best practices within the immunoassay group

• Strong experience with ligand binding assay platforms such as MSD, Gyrolab, ELISA, and other immunoassay technologies
• Deep understanding of assay formats including sandwich, competitive, bridging, and cell based assays
• Strong understanding of PK, ADA, neutralising antibody (NAb), and biomarker assay principles
• Experience with assay analysis and data interpretation software such as SoftMax Pro, Discovery Workbench, or equivalent platforms
• Familiarity with LIMS and electronic data management systems used within regulated laboratories
• Deep understanding of quantitative bioanalysis principles, including assay sensitivity, selectivity, precision, robustness, cut point determination, and drug tolerance

• Monoclonal antibodies and therapeutic proteins
• Bispecific antibodies and fusion proteins
• Gene therapy and oligonucleotide related biomarker strategies
• Antibody drug conjugates and related biologics
• Biomarker and immunogenicity assays supporting complex therapeutic programmes

• Extensive experience working under GLP and GCP
• Strong understanding of regulatory guidance relating to bioanalysis and immunogenicity assessment (FDA, EMA, MHRA)
• Experience supporting client audits and regulatory inspections
• Proven ability to lead scientific discussions with clients and defend assay approaches, validation strategies, and data
• Ability to communicate complex scientific issues clearly and confidently to both technical and non technical audiences
• Confidence to challenge client assumptions where appropriate and provide scientifically robust alternatives

Required:

• PhD in Immunology, Biochemistry, Biological Sciences, or related field, or MSc with significant industry experience
• Typically 10 to 15 or more years of immunoassay bioanalysis experience within a CRO or pharmaceutical environment
• Demonstrated expertise in assay development, validation, transfer, and advanced troubleshooting
• Strong track record supporting complex PK, ADA, NAb, and biomarker programmes across multiple studies and client