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

• Scientific, Technical and Regulatory: 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.
• People: 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.
• Strategic and Financial: 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.
• The post-holder is responsible for ensuring that all the above processes are performed in accordance with: Definitive study protocols, The current ICH for GCP & ICH M10 Guideline, UK Clinical Trial Statutory Instruments, Current Health and Safety Legislation and ACM HR policies,Other legislation that is relevant to the responsibilities of the post, ACM SOPs.
  

MINIMUM QUALITIFICATIONS

• 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.
   

PHYSICAL REQUIREMENTS:

Sedentary - Sedentary roles are primarily office-based and require prolonged sitting (67–100% of the workday) with minimal physical effort and lifting limited to under 10 lbs. Fine motor skills are necessary for computer work, writing, and telephone use, supported by clear visual and auditory ability. Cognitive and emotional demands are high due to extended concentration, frequent interruptions, independent decision-making, and information processing. Although physical exposure is low, administrative areas within healthcare environments may occasionally involve contact with infectious agents. Some roles may require flexible hours, TB screening, or a valid driver’s license.

Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.