Associate Director, R&D Laboratory

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. This role will lead laboratory operations, ensure regulatory compliance, and drive high-quality test development and execution within the R D environment.

PRIMARY RESPONSIBILITIES AND DUTIES

Laboratory Operations:

• Lead and direct the development, communication, and implementation of effective laboratory-related work processes across the R D laboratory

Test Development & Execution:

• Lead the implementation of high quality, effective test processes
• Ensure acceptable levels of analytic performance throughout the testing lifecycle

Resource & Infrastructure Management:

• Ensure personnel, reagent, and equipment resources are in place to support laboratory operations
• Partner with Facilities to maintain appropriate research environments

Regulatory & Quality Compliance:

• Maintain compliance with Celcuity's Quality Management System (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 laboratory improvements

Workflow Management:

• Oversee laboratory workflows from sample receipt through analysis, reporting, inventory, and equipment management

Leadership & Team Development:

• Lead, coach, and mentor laboratory 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 overall laboratory operations strategy

QUALIFICATIONS AND SKILLS

Education & Experience:

• BS, MS, or PhD in Life Sciences with 8-12 years of relevant experience
• Experience leading teams within CLIA-certified, CAP-accredited, GLP laboratories or pharma R D environments
• Strong knowledge of regulatory standards (CLIA, CAP, FDA, GCP, GLP)
• Demonstrated leadership, problem-solving, and organizational capabilities

About Us:

Celcuity is a clinical-stage, publicly traded biotechnology company seeking to extend the lives of cancer patients through the development of targeted therapies for the treatment of multiple solid tumor indications. The company was founded to develop a better way to treat the cellular drivers of tumor growth. Our lead therapeutic candidate, gedatolisib, is an intravenously administered, potential first-in-class PI3K/AKT/mTOR (PAM) pathway inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. Gedatolisib phase 3 clinical development programs are focused on the treatment of patients with

HR+/HER2- ABC

in the 1L and 2L settings. A Phase 1b/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is on-going. Celcuity is an Equal-Opportunity Employer. Celcuity is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are competitive. For this role, the anticipated base pay range is $150,000-$180,000 DOE. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's geography, qualifications, skills, and experience.