Assoc Director, Quality Control

Associate Director, Quality Control Analytical Tech Services

Kite is dedicated to curing cancer and is seeking a highly motivated individual to join us as an Associate Director, leading the Quality Control Analytical Tech Services group, reporting to the Senior Director, Quality Control in Frederick, MD. In this role, you will lead a group and work closely with the Senior Director and other Associate Directors on supporting commercial operations in CAR-T technology. You will work on complex projects involving qPCR / ddPCR, Flow cytometry and cell-based bioassays and lead efforts in automation development for analytical assays. You will have cross-functional interaction with personnel from other groups such as Quality Assurance, Analytical Development, Manufacturing, Material Management (MM) and Corporate teams.

Position Responsibilities (include but not limited to) :

• Provide technical support, process trending and procedural updates
• Lead method validation and method transfers support continuous improvement
• Lead and support method development, validations, and transfers
• Support laboratory investigations, deviations, CAPAs, change control as needed
• Assist in investigation, identify root cause for critical deviations and determine CAPA for QC as needed
• Establish data analytics to serve as metrics for monitoring trends in methods, products, and invalids
• Support incoming tech transfers from AD / PD as needed
• Author technical reports and protocols in support of cGMP activities
• Supervise, train, and mentor junior staff
• Create and / or revise procedures, SOPs, and test methods as needed
• Support equipment and software lifecycle process
• LIMS development and integration
• Provide technical expertise for AD / PD, QA, Regulatory, Manufacturing, and Supply Chain as needed
• Support and participate in inspection readiness plans and participate in compliance audits (internal and external) and regulatory inspections
• Follow technology changes, recommends new technologies, advises on technology purchases and implementation if appropriate
• Additional duties as assigned.

Basic Qualifications :

Preferred Qualifications :