Associate Director, QC Analytics – Lead CAR-T Testing

Kite Pharma; Frederick (MD); On-site; USD 165,000 - 214,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Discretionary annual bonus

Stock-based long-term incentives

Paid time off

Job summary

Kite Pharma in Frederick, MD is seeking an Associate Director to lead the Quality Control Analytical Technical Services group, reporting to the Senior Director of Quality Control. The role focuses on qPCR/ddPCR, flow cytometry, cell-based bioassays, and automation development for analytical assays in CAR-T technologies.

Responsibilities include method validation, transfers, investigations, CAPAs, and cross-functional collaboration with QA, Analytical Development, Manufacturing, MM, and corporate

Qualifications

• Advanced scientific degree (i.e. MD, PharmD, PhD) and 2+ years’ experience in biologics/cell-gene therapy in QC Analytical, Analytical Development environment OR
• Master’s Degree and 8+ years’ experience in biologics/cell-gene therapy in QC Analytical, Analytical Development environment OR
• Bachelor’s Degree and 10+ years’ experience in biologics/cell-gene therapy in QC Analytical, Analytical Development environment OR
• High School Degree and 14+ years’ experience in biologics/cell-gene therapy in QC Analytical, Analytical Development environment

Responsibilities

• Provide technical support, process trending and procedural updates
• Lead method validation and method transfers to support continuous improvement, to support method/product/invalid trending, and to investigate laboratory/assay related findings
• 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
• Provide technical expertise for AD/PD, QA, Regulatory, Manufacturing, and Supply Chain as needed
• Support and participate inspection readiness plans and participate during 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.

Skills

qPCR/ddPCR

Flow cytometry

Cell-based bioassays

Automation development for analytical

Cross-functional collaboration

Education

Advanced degree (MD/PhD/PharmD)

Master's Degree

Bachelor's Degree

High School Degree

Tools

LIMS

Job description

Kite Pharma in Frederick, MD is seeking an Associate Director to lead the Quality Control Analytical Technical Services group, reporting to the Senior Director of Quality Control. The role focuses on qPCR/ddPCR, flow cytometry, cell-based bioassays, and automation development for analytical assays in CAR-T technologies.

Responsibilities include method validation, transfers, investigations, CAPAs, and cross-functional collaboration with QA, Analytical Development, Manufacturing, MM, and corporate