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Associate Director, R&D Laboratory

1 month ago
United States
Full-time
Lead
Operations Manager
Quality Assurance and Testing
GCP
Apply Now
Celcuity

Celcuity

Celcuity is a clinical stage biotechnology company that unravels complexity and harnesses insights to develop targeted therapies for cancer patients. Their platform provides unparalleled insights into oncogenic pathways, with their lead candidate being...

Biotechnology
11-50
Founded 2012
$214M raised
View All Jobs 10

Description

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

Requirements

  • BS, MS, or PhD in Life Sciences.
  • 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 including CLIA, CAP, FDA, GCP, and GLP.
  • Demonstrated leadership, problem-solving, and organizational capabilities.
  • Experience working in a high-complexity clinical laboratory environment.
  • Experience with quality management systems, documentation, and QA/QC processes.
  • Ability to support operational planning and resource management.

Benefits

  • Competitive base salary of $150,000–$180,000 DOE.
  • Total compensation package designed to be competitive.
  • Equal-opportunity employer commitment.

Interested in this position?

Apply directly on the company website

Apply Now

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