Summary

The GMP Lab within the Department of Pediatrics is seeking a Laboratory Director to oversee the Quality Control efforts of the lab. The laboratory analyzes more than 6000 clinical research samples for more than 15 clinical trials. An understanding of vector production is required as this position requires constant interaction with the vector production facility where Investigational New Drugs are produced for investigators from around the world. This position requires deep knowledge of the FDA and European regulations for manufacturing and testing of cell and gene therapy products, day-to-day supervision of laboratory operations and personnel management. The position requires an in-depth understanding of working within the standard framework of a clinical laboratory, interpretation of laboratory results, CAP/CLIA certification requirements and HLA requirements for laboratory selections.

Job Duties

• Ensure compliance with manufacturing and testing of cell and gene therapy products for clinical trials in humans.
  • Ensure all tests are performed according to approved SOPs, test methods, and regulatory guidelines.
  • Review the results of testings, production records, plan weekly laboratory activities.
  • Maintain accurate, complete, and contemporaneous laboratory records in compliance with ALCOA+ principles. Identify and investigate out-of- specification (OOS) or invalid results.
  • Participate in internal audits and support external regulatory inspections.
• Execute Environmental Monitoring (EM) & Cleanroom Support.
  • Perform viable and non-viable environmental monitoring in GMP suites.
  • Trend EM data and escalate findings outside of established action/alert limits.
  • Support investigations related to contamination or deviations.
• Manage Laboratory Equipment & Calibration.
  • Perform and document routine calibration, maintenance, and troubleshooting of QC instruments.
  • Perform equipment qualification for new equipment.
• Support Method Development and Validation.
  • Preparation of validation plans, SOPs and reports.
• Ensure samples handling for shipments and Chain of Custody.
• Maintain traceability and prevent mix-ups through strict adherence to sample tracking procedures.
• Participate in Training & Competency Assessments.
  • Specific duties include GMP training completion.
  • Train staff members on procedures and oversee personnel's annual training and competency completion.
• Interact with Investigators around the world to design and manage specialized testing to comply with FDA and European regulations such as vector viability over time.
• Research new tests recommended by regulatory agencies and design plans to develop and validate these assays.
• Prepare SOPs and train staff.
• Perform other job related duties as needed.

Minimum Qualifications

• Bachelor's degree in a Basic Science or a related field.
• Five years of relevant experience, with prior supervisory experience.

Preferred Qualifications

• PhD or Master degree in a Basic Science or related field.
• Knowledge of GMP and FDA regulations.