Position Summary

The Translational Laboratory Manager for the Columbia Initiative in Cell Engineering and Therapy (CICET) provides strategic and operational leadership for the Translational Laboratory and supports cell and gene therapy clinical and translational research programs.

Reporting to the Director of CICET and working in close collaboration with the Scientific Director of the CICET Translational Laboratory, this role oversees laboratory operations, correlative study execution, and personnel management, including direct supervision of the Cell Therapy Correlative Study Specialist.

The Translational Laboratory Manager is responsible for ensuring the generation of high-quality and reproducible data from patient-derived samples to support clinical studies, biomarker development, and mechanistic understanding of investigational cell and gene therapy products. This role integrates laboratory operations and research assays, including spectral flow cytometry, Olink proteomics, single-cell RNAseq, and spatial transcriptomics, with clinical trial timelines, ensuring delivery of correlative endpoints aligned with protocol requirements, institutional priorities, and sponsor expectations.

Responsibilities

The Translational Laboratory Manager provides strategic, scientific, and operational leadership for the CICET Translational Laboratory, ensuring the efficient execution of correlative studies supporting cell and gene therapy clinical trials. This role integrates laboratory operations with clinical and translational objectives to deliver high-quality and timely research outputs.

Laboratory Operations and Management

• Lead and manage the daily operations of the CICET Translational Laboratory, ensuring efficient and high-quality execution of all laboratory activities.
• Oversee laboratory personnel, including direct supervision, training, and performance management of the Cell Therapy Correlative Study Specialists.
• Ensure laboratory readiness, organization, and compliance with institutional biosafety, regulatory, and quality standards.
• Oversee laboratory space planning, workflow optimization, and operational efficiency initiatives.
• Manage laboratory budgets, resource allocation, and cost control to ensure operations remain on time and within budget.
• Ensure all project-related expenses are accurately allocated and charged to the appropriate sponsor-designated budgets in accordance with financial and contractual requirements.

Correlative Studies and Scientific Oversight

• Partner with Principal Investigators, the Scientific Director of the CICET Translational Laboratory, and the Director of CICET to design and implement correlative study plans for clinical studies.
• Oversee execution of immune monitoring, biomarker, and translational assays using patient-derived samples.
• Ensure scientific rigor, assay reproducibility, and data integrity across all correlative studies.
• Guide development, validation, and implementation of assay panels and analytical workflows.
• Support interpretation of translational data to inform clinical development and mechanistic insights.

Sample Management and Clinical Integration

• Oversee end-to-end lifecycle of clinical samples, including collection coordination, processing, storage, tracking, and data integration.
• Ensure alignment of laboratory workflows with clinical trial protocols, timelines, and regulatory requirements.
• Collaborate closely with CICET Clinical Trials Management to ensure seamless sample logistics and protocol adherence.
• Establish and maintain robust chain-of-custody, biobanking, and sample tracking systems.

Equipment, Facilities, and Compliance

• Oversee validation, maintenance, and lifecycle management of laboratory equipment and instrumentation.
• Coordinate preventive maintenance, service contracts, and vendor relationships for laboratory systems.
• Ensure compliance with institutional, federal, and sponsor requirements, including biosafety, GCP-aligned practices, and data integrity standards.
• Maintain laboratory policies and documentation frameworks to support consistent operations.

Program Management and Deliverables

• Ensure that laboratory deliverables are achieved according to agreed-upon clinical and operational timelines.
• Monitor project progress, identify risks, and implement mitigation strategies to ensure the successful execution of translational objectives.
• Align laboratory priorities with CICET programmatic goals and clinical development milestones.
• Oversee primary data analysis, including spectral flow cytometry, Olink proteomics, single-cell RNAseq, and spatial transcriptomic datasets in collaboration with Cell Therapy Correlative Study Specialist and bioinformatician support.
• Prepare translational results for internal governance, sponsors, and regulatory submissions.

Stakeholder Engagement and Collaboration

• Serve as a key interface between the Translational Laboratory and CUIMC stakeholders, including clinical investigators, research teams, and institutional leadership.
• Collaborate with CICET GMP/QC teams, external partners, and collaborators to support integrated translational efforts.
• Facilitate cross-functional communication to ensure alignment across clinical and translational activities.

Continuous Improvement and Innovation

• Drive continuous improvement of laboratory workflows, assay platforms, and operational processes.
• Implement best practices in translational research, including the adoption of emerging technologies and methodologies.
• Support grant applications, publications, and scientific presentations related to translational research efforts.

Minimum Qualifications

• Bachelor’s degree in Biology, Immunology, Molecular Biology, or related life science discipline.
• Minimum of four (4) years of relevant laboratory experience, including experience in translational or clinical research environments.
• Demonstrated experience managing laboratory operations, personnel, and workflows.
• Experience handling human clinical samples (e.g., blood, bone marrow, tissue).
• Hands-on experience with PCR-based assays.
• Hands-on experience with designing and validating spectral flow cytometry panels of >20 colors.
• Strong organizational, project management, and communication skills.
• Ability to work effectively in a multidisciplinary and fast-paced academic medical center environment.

Preferred Qualifications

• PhD degree in a related life science discipline.
• Minimum of 1-2 years of relevant laboratory experience supporting correlative studies for cell or gene therapy clinical trials, preferably in immunology-focused research.
• Hands-on experience in sample preparation for single-cell genomics assays.
• Familiarity with immune monitoring, transcriptomics, biomarker development, or translational assay workflows.