Associate Director, R&D Laboratory
Celcuity
June 26, 2026
On-site
Minneapolis, MN
Clinical Research and Development
Position Summary
- Reporting to the Chief Science Officer/Technical Supervisor, the Associate Director, R&D Laboratory is responsible for the overall operation and administration of a CLIA-certified, CAP-accredited, GLP high-complexity clinical laboratory.
- Lead laboratory operations, ensure regulatory compliance, and drive high-quality test development and execution.
Responsibilities
Laboratory Operations
- Lead and direct the development, communication, and implementation of effective laboratory work processes across the R&D laboratory.
Test Development & Execution
- Lead implementation of high-quality, effective test processes.
- Ensure acceptable analytic performance throughout the testing lifecycle.
Resource & Infrastructure Management
- Ensure personnel, reagent, and equipment resources are in place.
- Partner with Facilities to maintain appropriate research environments.
Regulatory & Quality Compliance
- Maintain compliance with Celcuity’s QMS, including documentation, QA/QC processes, and regulatory standards (CLIA, CAP, GLP).
Continuous Improvement
- Define test specifications and QC criteria.
- Address Non-Conforming Events (NCEs) and implement continuous improvements.
Workflow Management
- Oversee workflows from sample receipt through analysis, reporting, inventory, and equipment management.
Leadership & Team Development
- Lead, coach, and mentor staff.
- Ensure training and competency requirements are met.
Technical Oversight
- Resolve technical problems and implement corrective actions.
- Ensure test systems operate within established performance specifications.
Operational Planning
- Participate in budgeting, resource planning, and laboratory operations strategy.
Qualifications & Skills
- BS, MS, or PhD in Life Sciences with 8–12 years of relevant experience.
- Experience leading teams in CLIA-certified, CAP-accredited, GLP labs or pharma R&D environments.
- Strong knowledge of regulatory standards (CLIA, CAP, FDA, GCP, GLP).
- Demonstrated leadership, problem-solving, and organizational capabilities.
- Reporting to the Chief Science Officer/Technical Supervisor, the Associate Director, R&D Laboratory is responsible for the overall operation and administration of a CLIA-certified, CAP-accredited, GLP high-complexity clinical laboratory.
- Lead laboratory operations, ensure regulatory compliance, and drive high-quality test development and execution.
Responsibilities
Laboratory Operations
- Lead and direct the development, communication, and implementation of effective laboratory work processes across the R&D laboratory.
Test Development & Execution
- Lead implementation of high-quality, effective test processes.
- Ensure acceptable analytic performance throughout the testing lifecycle.
Resource & Infrastructure Management
- Ensure personnel, reagent, and equipment resources are in place.
- Partner with Facilities to maintain appropriate research environments.
Regulatory & Quality Compliance
- Maintain compliance with Celcuity’s QMS, including documentation, QA/QC processes, and regulatory standards (CLIA, CAP, GLP).
Continuous Improvement
- Define test specifications and QC criteria.
- Address Non-Conforming Events (NCEs) and implement continuous improvements.
Workflow Management
- Oversee workflows from sample receipt through analysis, reporting, inventory, and equipment management.
Leadership & Team Development
- Lead, coach, and mentor staff.
- Ensure training and competency requirements are met.
Technical Oversight
- Resolve technical problems and implement corrective actions.
- Ensure test systems operate within established performance specifications.
Operational Planning
- Participate in budgeting, resource planning, and laboratory operations strategy.
Qualifications & Skills
- BS, MS, or PhD in Life Sciences with 8–12 years of relevant experience.
- Experience leading teams in CLIA-certified, CAP-accredited, GLP labs or pharma R&D environments.
- Strong knowledge of regulatory standards (CLIA, CAP, FDA, GCP, GLP).
- Demonstrated leadership, problem-solving, and organizational capabilities.