Lead Large Molecule Bioanalysis Specialist

955 ACM UK; York and North Yorkshire; On-site; GBP 55,000 - 75,000; Full time

Job summary

955 ACM UK is seeking a Technical Specialist in Large Molecule Bioanalysis at our York onsite facility. The role covers development, validation, troubleshooting, and lifecycle management of LBAs supporting PK/TK, ADA, and biomarker assays, with emphasis on regulatory compliance and data integrity.

The candidate will lead method development, oversee equipment lifecycle, and mentor lab scientists while ensuring safety, audits readiness, and continuous improvement across assays and platforms such

Qualifications

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

Responsibilities

• Act as the technical 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 GLP/GCP compliance across all bioanalytical work.
• Maintain oversight of analytical platforms (e.g. ELISA, MSD) and supporting equipment.
• Lead equipment lifecycle management, including evaluation, qualification, and validation.
• Monitor and ensure 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 for assay robustness, efficiency, and data quality.
• Oversee SOP reviews, ensuring regulatory alignment.
• Support audits/inspections and resolution of findings.
• Provide hands-on guidance and mentorship to laboratory scientists.
• Mentor and trainer for Laboratory Scientists; support recruitment and onboarding.
• Partner with management to optimize team performance and resource allocation.
• Provide actionable feedback to support prioritisation and timelines.
• Drive KPIs for productivity and customer satisfaction.

Skills

Bioanalytical science

Regulatory compliance

Experimental design

Troubleshooting

Mentorship

Education

BSc or higher in scientific subject

8+ years bioanalytical lab experience

Tools

ELISA

MSD

Job description

955 ACM UK is seeking a Technical Specialist in Large Molecule Bioanalysis at our York onsite facility. The role covers development, validation, troubleshooting, and lifecycle management of LBAs supporting PK/TK, ADA, and biomarker assays, with emphasis on regulatory compliance and data integrity.

The candidate will lead method development, oversee equipment lifecycle, and mentor lab scientists while ensuring safety, audits readiness, and continuous improvement across assays and platforms such