Team Lead, Quality Control Analytical

We are seeking a highly motivated individual to join us as a Team Lead, Quality Control. You will report into the Sr. Manager, Quality Control in Frederick, MD and be a hands-on resource for QC Analytical. Initially as part of the start-up activities, you will be responsible for executing Assay Technical Transfers including being trained on all the Analytical Assays and implementing and Train-the-Trainer program. As the site transitions into operations mode, you will be responsible for the day to day oversight of the QC Analytical team. This group will operate 7 days a week, with an extended, overlapping shift structure.

Additional Responsibilities (include but are not limited to):

• Training on Analytical Assays
• Team Lead of all QC Analytical laboratory testing
• Management of QC Analytical training program
• Work with QC raw materials team to establish testing process of raw materials.
• Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release.
• Generation of CoAs for product release
• Develop, revise, and review SOPs, tech transfer/qualification/validation protocols and reports
• Conduct investigations regarding out of specifications (OOS) results, trends in invalid assay and address and manage deviations related to QC Analytical procedures
• Identify and lead teams for lean improvement activities
• Provide updates at daily and weekly meetings
• Monitor the GMP systems currently in place to ensure compliance with documented policies
• Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate
• Other duties as assigned
• 50% Travel during start-up activities

Requirements:

• BS or BA in Biotechnology, Biological Sciences or related discipline and 7 years of relevant experience or MS in Biotechnology, Biological Sciences or related discipline and 4 years of relevant experience
• Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team based environment.
• Minimum of 7 years' experience working in Quality Control or biopharma laboratories.
• Minimum of 3 years' experience supervising/managing analytical biology labs within the biotechnology or pharmaceutical industry
• Well versed in various analytical techniques such as Flow Cytometry, ELISA, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals.
• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
• Quality Control, GMPs, method development and validation

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Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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