Study Director, Immunochemistry

Job Responsibilities:

Strong expertise in ligand binding assay (LBA) development,validation, and sample analysis for pharmacokinetic (PK) and anti-drug antibody(ADA) bioanalysis in support of preclinical and clinical drug development programs.

This role requires a scientific leader who can independently develop and troubleshoot assays, manage project deliverables, mentor junior scientists, and contribute directly to client success.

Assay Development & Validation

• Design, develop, optimize, and validate ligand binding assays for PK, ADA, and other biomarker applications in accordance with applicable SOPs, regulatory guidelines, and industry best practices.
• Lead scientific troubleshooting and implement appropriate assay improvements to address technical challenges.
• Perform method transfer, qualification, and validation activities to support study requirements.
• Evaluate assay performance characteristics and ensure methods are robust, reliable, and fit for purpose.

Bioanalysis & Data Review

• Analyze biological samples using validated methods while ensuring compliance with regulatory requirements and laboratory procedures.
• Review, interpret, and evaluate analytical data to ensure accuracy, quality, and scientific integrity.
• Perform quality control (QC) review of experimental data and study documentation.
• Maintain complete, accurate, and audit-ready laboratory records.

Project Leadership

• Serves as a Study Director / Principal Investigator /Responsible Scientist for research studies. Take on overall responsibility for the technical conduct of a study, analytical direction,review, documentation and reporting of results. All activities are conducted in compliance with appropriate SOPs and regulatory agency guidelines.
• Plan, monitor, and coordinate laboratory activities to ensure timely delivery of project milestones.
• Effectively manage resources and prioritize workloads to meet client and study timelines.
• Participate in project meetings and provide technical expertise and recommendations to stakeholders.

Equipment & Laboratory Operations

• Independently operate, maintain, troubleshoot, and perform routine and non-routine maintenance of laboratory equipment.
• Identify equipment or process-related issues and implement effective corrective actions.
• Support laboratory compliance, operational excellence, and continuous improvement initiatives.

Mentorship & Scientific Contribution

• Train, mentor, and provide technical guidance to junior scientists and laboratory staff.
• Review and contribute to study protocols, validation plans,reports, methods, and SOPs.
• Participate in process improvement and innovation initiatives to enhance laboratory efficiency and scientific quality.

Client Interaction

• Participate in client meetings, teleconferences, and site visits as needed.
• Communicate scientific findings, study progress, and technical recommendations effectively to clients and internal stakeholders.

Minimum Qualifications:

• Bachelor Degree in Biochemistry, Immunology, Analytical Chemistry, Pharmaceutical Sciences.
• Extensive hands-on experience in ligand binding assay development and validation, with a strong focus on PK and ADA bioanalysis.
• Demonstrated expertise in immunoassay platforms such as ELISA, ECL(MSD), Gyrolab, or other relevant technologies.

Preferred Qualifications:

• Experience supporting regulated GLP and/or GCLP bioanalytical studies.
• Strong understanding of regulatory requirements and industry guidance related to bioanalytical method validation.
• Prior experience leading projects and mentoring junior scientists.
• Direct client-facing experience in a CRO or pharmaceutical/biotechnology environment.

Additional Job Standards:

• Proven ability to independently troubleshoot complex assay and analytical challenges.
• Excellent data analysis, scientific writing, and communication skills.

At Labcorp we have a passion for helping people live happy and healthy lives. Every day we provide vital information that helps our clients and patients understand their health. If you are passionate about helping people and have a drive for service, then Labcorp could be a great next career step!