Senior Large Molecule Bioanalysis Scientist

ACM Global Laboratories, Inc.; York and North Yorkshire; On-site; GBP 45,000 - 65,000; Full time

Job summary

Rochester Regional Health is seeking a Technical Specialist in Large Molecule Bioanalysis to lead development, validation, and troubleshooting of LBAs (PK/TK, ADA, biomarkers) in a GLP/GCP environment.

The role focuses on assay design, data integrity, and regulatory compliance, with oversight of ELISA and MSD platforms, equipment lifecycle, and CSV/software validation. Onsite in York, 37.5 hours/week.

Qualifications

• BSc (or equivalent) or higher in a relevant scientific subject.
• A minimum of 5 years’ experience within a bioanalytical laboratory environment.
• Experience with GLP/GCP regulatory requirements and lifecycle management of LBAs.

Responsibilities

• Act as SME for large molecule bioanalysis (PK/TK, ADA, biomarkers).
• Design, develop, validate, and implement LBA methods per regulatory guidance.
• Independently manage method development, transfer, validation, and study support.
• Lead troubleshooting and ensure data integrity and regulatory compliance.

Skills

LBA methods

Regulatory compliance

Scientific leadership

Education

BSc in a relevant scientific subject

Tools

ELISA

MSD

Job description

Rochester Regional Health is seeking a Technical Specialist in Large Molecule Bioanalysis to lead development, validation, and troubleshooting of LBAs (PK/TK, ADA, biomarkers) in a GLP/GCP environment.

The role focuses on assay design, data integrity, and regulatory compliance, with oversight of ELISA and MSD platforms, equipment lifecycle, and CSV/software validation. Onsite in York, 37.5 hours/week.