Assoc Director, Quality Control

Arbeitsbeschreibung

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!

We are seeking a highly motivated individual to join us as an Associate Director, to lead 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, 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 lifecyle process

• LIMS development and integration

• 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.

Basic 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

Preferred Qualifications:

• Experience supervising/managing analytical labs within the biotechnology or pharmaceutical industry

• Well versed and experienced in bioanalytical methods working under GMP conditions.

• Deep experience in applying GMP in QC lab in conformance to US, EU and ROW standards.

• Experience in conducting investigations, writing deviations, implementing CAPA and initiating change controls.

• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211), Quality Control, GMPs, GLP

• Ability to effectively negotiate and develop collaboration within teams and amongst individuals.

• Demonstrated ability to create and maintain highly functioning teams.

• Excellent interpersonal, verbal and written communications skills which are essential in this collaborative work environment

• Comfortable in a fast-pace small company environment with minimal direction and able to adjust workload based on changing priorities.