Technical Specialist, Large Molecule Bioanalysis

Job Title: Technical Specialist, Large Molecule Bioanalysis Department: Bioanalytical Laboratory Location: Onsite; York, UK Hours Per Week: 37.5 Schedule: Monday – Friday, 9:00 AM – 5:00 PM

SUMMARY

A Technical Specialist is responsible for the development, validation, troubleshooting, and lifecycle management of ligand binding assays (LBAs) supporting regulated (GLP/GCP) and non-regulated bioanalytical studies. The role ensures scientific integrity, regulatory compliance, and operational excellence across PK/TK, ADA, and biomarker assays.

RESPONSIBILITIES

• Act as the technical subject‑matter expert (SME) for large molecule bioanalysis (PK/TK, ADA, biomarkers)
• Design, develop, validate, and implement robust LBA methods in line with current regulatory guidance
• Independently manage method development, transfer, validation, and study support activities
• Provide scientific and technical leadership, ensuring appropriate assay design and data integrity
• Lead troubleshooting of assays and instrumentation, providing timely support to laboratory teams
• Ensure all bioanalytical work is conducted in full compliance with GLP/GCP requirements
• Maintain oversight of analytical platforms (e.g. ELISA, MSD) and supporting laboratory equipment
• Lead equipment lifecycle management, including evaluation, procurement, qualification, and validation
• Support and oversee computerised system validation (CSV) and software compliance activities
• Ensure compliance with COSHH, health & safety, and environmental regulations
• Lead or support laboratory investigations, deviations, and CAPA management
• Drive continuous improvement initiatives to enhance assay robustness, efficiency, and data quality
• Oversee the review and approval of SOPs, ensuring alignment with regulatory expectations
• Support internal and external audits/inspections, including resolution of findings
• Provide hands‑on technical guidance and mentorship to laboratory scientists
• Act as a point of escalation for complex scientific or operational challenges
• Promote a culture of quality, compliance, and scientific excellence within the laboratory
• Maintain current knowledge of GLP, GCP, and industry best practices in bioanalysis
• Ensure all activities are conducted in a safe, compliant, and inspection-ready manner
• Demonstrate ownership, accountability, and proactive problem‑solving across all responsibilities
• Act as a mentor and technical trainer for Laboratory Scientists; support recruitment and onboarding activities as required
• Partner with departmental management to ensure effective team and individual performance, aligned to business objectives
• Provide clear, actionable feedback to support prioritisation and delivery against critical timelines and commitments
• Support optimisation of laboratory resourcing (people, equipment, facilities) to ensure efficient and effective study delivery
• Drive the ACM Mission, Vision and Core Values with every interaction, Foster a culture of quality, compliance, safety, customer focus, and individual accountability
• Support Operational Management in the development and execution of long‑term business and operational strategies
• Monitor and interpret financial and operational metrics, using data to inform decision‑making, resource allocation, and process improvements
• Provide timely, transparent updates to management on laboratory performance, risks, and any deviations from agreed objectives
• Drive and track key performance indicators (KPIs) to ensure high levels of productivity, efficiency, and customer satisfaction

MINIMUM QUALIFICATIONS

• BSc (or equivalent) or higher in a relevant scientific subject
• A minimum of 5 years’ experience within a bioanalytical laboratory environment

PREFERRED QUALIFICATIONS

• BSc (or equivalent) or higher in a relevant scientific subject
• 8 years’ experience within a bioanalytical laboratory environment

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