Technical Specialist, Large Molecule Bioanalysis

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

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