Lab Supervisor – Bioanalytical; Ligand Binding Assays

Position Summary

The Lab Supervisor, Bioanalytical (Ligand Binding Assays), is responsible for overseeing the daily operations of a regulated bioanalytical laboratory supporting ligand binding assay (LBA) studies within a Contract Research Organization (CRO). This role ensures high-quality, compliant execution of immunoassays (e.g., ELISA, MSD) used in pharmacokinetic (PK), immunogenicity (ADA), Neutralizing Antibody (Nab) and biomarker analysis in support of preclinical and clinical programs.

• 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.
• Provide support for laboratory operations by addressing and resolving issues that may arise.
• Other duties as assigned.

• Provide subject matter expertise in ligand binding assay platforms (ELISA, ECL/MSD, etc.).
• Assist with 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).
• Serve 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.

• 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, Soft Max 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.

• Leadership & team development
• Technical expertise in bioanalysis
• Problem‑solving & critical thinking
• Strong communication & stakeholder management
• Attention to detail & data integrity focus
• Organizational and time management skills

• Laboratory‑based role within a regulated CRO environment.
• May require occasional extended hours to meet study deadlines.
• Interaction with cross‑functional teams, including QA, project management, and clients.