Supervisor, Quality Control Analytical

Job Description

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a 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 a Supervisor, Quality Control Analytical, reporting to the Associate Director, Quality Control in Frederick, MD. In this role, you will be responsible for tasks associated with managing a group responsible for analytical testing and release of cell therapy final product using techniques such as qPCR/ddPCR, Flow cytometry, Cell-culture-ELISA and will have cross-functional interaction with personnel from other QC groups, Quality Assurance, Analytical Development, Manufacturing, Material Administration (MM) and teams.

** Shift: Wed-Sat 1pm – 11pm **

Position Responsibilities (include but are not limited to):

• 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.
• Manages QC Analytical training program
• Hire, mentor and develop exceptional QC personnel
• Works with QC raw materials team to establish testing process of raw materials
• Generates of CoAs for product release
• Develops, revises, and reviews 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
• Monitors 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
• Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate
• Other duties as assigned

Basic Qualifications:

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

Preferred Qualifications:

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

Does this sound like you? If so, apply today!

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