Supervisor, Quality Control

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Every moment is dedicated to developing treatments that cure cancer. Kite Pharma’s pioneering CAR T‑cell therapies have changed the paradigm, and we are seeking a highly motivated individual to join us as a Supervisor, Quality Control Analytical in Frederick, MD.

This role reports to the Associate Director, Quality Control. You will manage a group responsible for analytical testing and release of cell therapy final product using techniques such as qPCR/ddPCR, Flow Cytometry, Cell‑culture ELISA. Cross‑functional interaction will occur with personnel from QC, Quality Assurance, Analytical Development, Manufacturing, and Material Administration teams. The position is a night shift (Monday through Friday, 11:00 pm to 7:30 am) working 40‑hour weeks.

• Training on Analytical Assays using qPCR/ddPCR, Flow Cytometry, Cell‑culture ELISA
• Supervise all QC Analytical laboratory testing using qPCR/ddPCR, Flow Cytometry, Cell‑culture ELISA
• Responsible for the efficient operation of the QC Analytical labs including the planning, coordination and supervision of activities conducted by QC Analysts
• Manage QC Analytical training program
• Hire, mentor and develop exceptional QC personnel
• Work with QC raw materials team to establish testing process of raw materials
• Generate CoAs for product release
• Develop, revise, and review SOPs, tech transfer/qualification/validation protocols and reports
• Conduct and/or develop investigation of OOS, aberrant results and trends in invalid assay in product and raw material testing
• Develop and author deviations related to QC Analytical procedures to investigate root cause, impact and corrective and preventative actions
• Participate and/or lead daily and weekly team meetings
• Monitor the GMP systems currently in place to ensure compliance with established SOPs, Policies, cGMPs and other relevant regulatory requirements; conduct investigations to support deviations when preferred
• Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate
• Author controlled documents such as SOPs, forms, etc., as needed
• Participate and support development and implementation of Operational Excellence initiatives to enhance laboratory and staff efficiencies
• Other duties as assigned

• MA / MS Degree with 3+ years of analytical and/or cGMP operations and/or quality experience
• BA/BS Degree with 5+ years of analytical and/or cGMP operations and/or quality experience
• High School Degree with 9+ years of analytical and/or cGMP operations and/or quality experience

• Experience supervising/managing analytical labs within the biotechnology or pharmaceutical industry
• Demonstrated guidance and overseeing skills, including establishing direction and goals, and guiding implementation while fostering a team‑based environment
• Well versed in various analytical techniques such as Flow Cytometry, ELISA, PCR, and cell bioassays and other applicable methods for the testing of biopharmaceuticals
• Excellent 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 deliver collaboration within teams and amongst team members
• 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

The salary range for this position is: $ - $. Additional compensation may include discretionary annual bonus, stock‑based incentives, paid time off, and a benefits package.

Benefits typically include company‑sponsored medical, dental, vision, and life insurance plans, as well as other employee benefits.

For more information on our compensation and benefits:

Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment. Employment decisions will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, veteran status, or other protected characteristics.

Notice:
Employee Polygraph Protection Act. Family and Medical Leave Act rights. This position does not disclose press confidentiality on compensation unless required by law.