Associate Director, R&D Laboratory

Celcuity Inc.•Plymouth, MN

2h•Onsite

About The Position

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. 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.

Requirements

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

Responsibilities

Lead and direct the development, communication, and implementation of effective laboratory-related work processes across the R&D laboratory
Lead the implementation of high quality, effective test processes
Ensure acceptable levels of analytic performance throughout the testing lifecycle
Ensure personnel, reagent, and equipment resources are in place to support laboratory operations
Partner with Facilities to maintain appropriate research environments
Maintain compliance with Celcuity’s Quality Management System (QMS), including documentation, QA/QC processes, and regulatory standards (CLIA, CAP, GLP)
Define test specifications and QC criteria
Address Non-Conforming Events (NCEs) and implement continuous laboratory improvements
Oversee laboratory workflows from sample receipt through analysis, reporting, inventory, and equipment management
Lead, coach, and mentor laboratory staff
Ensure training and competency requirements are met
Resolve technical problems and implement corrective actions
Ensure test systems operate within established performance specifications
Participate in budgeting, resource planning, and overall laboratory operations strategy