Lab Supervisor (Bioanalytical)

About the role

The Lab Supervisor, Bioanalytical (Ligand Binding Assays), oversees the daily operations of a regulated bioanalytical laboratory supporting ligand binding assay (LBA) studies within a Contract Research Organization (CRO).

Responsibilities

• Supervise and coordinate daily bioanalytical lab activities supporting LBA workflows.
• Ensure studies are executed on time and according to approved protocols, SOPs, and client expectations.
• Monitor assay performance, troubleshoot issues, and ensure data integrity.
• Allocate resources (staff, instruments, reagents) to meet study timelines and priorities.
• Maintain a safe and efficient laboratory environment.
• Support laboratory operations by addressing and resolving issues that may arise.
• Provide subject matter expertise in ligand binding assay platforms (ELISA, ECL/MSD, etc.).
• Aids in method qualification, validation, and sample analysis.
• Review assay data, identify trends, and guide troubleshooting/root cause investigations.
• Ensure adherence to regulatory expectations for assay performance (accuracy, precision, sensitivity, selectivity).
• Ensure compliance with GLP, GCP, 21 CFR Part 11, and relevant regulatory guidance (FDA, EMA).
• Serves as Test Site Management for reports, audits, and investigations, as applicable.
• Support audits (internal, client, regulatory inspections) and address findings with appropriate CAPAs.
• Ensure proper documentation practices and data integrity standards.
• Supervise, coach, and mentor bioanalytical scientists and technicians.
• Conduct performance reviews, training plans, and career development initiatives.
• Ensure staff are trained and qualified on applicable methods, instrumentation, and SOPs.
• Foster a collaborative, high-performance, and accountable team environment.
• Identify and implement process improvements to increase efficiency, quality, and throughput.
• Support adoption of new technologies and automation within LBA workflows.
• Contribute to SOP development, revision, and standardization.

Qualifications

• Bachelor’s degree in Biology, Biochemistry, Immunology, or related field (Master’s preferred).
• 5–8+ years of experience in bioanalytical laboratory environments, preferably within a CRO.
• 2+ years of supervisory or team leadership experience.
• Strong hands-on experience with ligand binding assays (ELISA, MSD, Gyrolab).
• Deep understanding of LBA method development, validation, and sample analysis.
• Experience with PK, ADA (screening, confirmatory, titer), and biomarker assays.
• Familiarity with laboratory data systems (e.g., LIMS, Watson, SoftMax Pro, Discovery Workbench).
• Strong data analysis and troubleshooting skills.
• Working knowledge of GLP/GCP and regulatory guidance for bioanalytical methods (ICH, FDA, EMA).
• Experience supporting audits and inspections.
• Experience in large molecule bioanalysis, ligand binding assays (monoclonal antibodies, biologics).
• Exposure to automation platforms or high-throughput assay systems.
• Experience with electronic lab notebooks and data integrity best practices.
• Management, supervisory experience preferred.