Public Service Division
Senior/Analytical Scientist (Method Development & Platform Innovation) – Contract position
Aberdeen City
Posted 2 days ago
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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.
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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.
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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).
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Skills
Bioassay Development
Analytical Method Validation
SPR
BLI
HRMS
SEC-HPLC
CEX-HPLC
HIC-HPLC
Cell-based Bioassays
Protein Characterisation
ICH Guidelines
ISO 17025
GLP
GMP
Project Management
Technical Reporting