Job Purpose

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.

Main Areas of Responsibility

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

Technical Expertise

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

Experience with Complex Modalities

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

Regulatory and Client Experience

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

Qualifications & Experience

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

PLEASE ENSURE THAT YOUR CV/RESUME IS SUBMITTED IN ENGLISH.

Synexa Life Sciences is committed to achieving transformation and will take it’s EE plan and targets into consideration during the selection process.

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