Sr. QC Microbiologist, Quality Control

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 a Senior QC Microbiologist, Quality Control. Reporting to the Senior Manager (Microbiology), Quality Control in Oceanside, CA, in this role, you will be responsible for the execution of QC Microbiological program and methods in support of tech transfer, validation, lot release and in-process testing.

The Sr. Microbiologist, under minimal supervision, will perform a broad range of activities to support the release of viral vector drug substances for clinical and commercial use. Responsible for the execution of raw material, in-process, final product testing, environmental monitoring and stability testing. Upkeep and maintenance of QC instrumentation and lab in GMP compliance. Work with outside testing labs and other Kite sites for method transfers. Ability and willingness to perform a wide variety of tasks - from those which are routine in nature to those which require independent thought and analysis.

Responsibilities (include but are not limited to):

• Support the transfer and validation of microbiological methods to Oceanside, CA, QC.
• Provide technical oversight and training of Microbiological methods from Development to QC (validation of methods and tech transfer of methods, including comparability).
• Complete routine record review of test data and related documents for raw material, in-process testing, drug-substance and drug product release. Generation of CoAs for product release.
• Conduct investigations regarding environmental monitoring (EM) action level excursions and out of specifications (OOS) results.
• Investigate and manage deviations related to microbiology procedures. Determine corrective/preventative actions (CAPA) and drive implementation.
• Generate trend reports on environmental monitoring and product release data. Frequently update management on trends. Implement corrective action plans when necessary.
• Gather metric information for use in continuous improvement of areas of responsibility.
• Develop, revise and review SOPs, qualification/validation protocols and reports.
• Assist in the management of laboratory activities and provide technical direction to staff.
• Assist in the preparation of dossiers and data packages for interactions between Kite and Regulatory agencies. Interact with agents from Regulatory agencies and participate in Pre-Approval Inspections.
• Monitor the GMP systems currently in place to ensure compliance with documented policies.
• Support the QC Microbiology and Aseptic Techniques Training programs.
• Support IT and QE to implement LIMS at Oceanside, CA
• Perform duties as needed

Skills/Qualifications

• 7+ years of experience with BS degree in Microbiology or related scientific discipline
• 5+ years of experience with MS degree in Microbiology or related scientific discipline
• Strong experience in application of microbiological techniques such as air monitoring, water testing, surface monitoring, genus and species identification of various microbes, aseptic techniques, sterile gowning procedures and clean room operations.
• Strong Experience in applying GMP in QC lab in conformance to U.S., EU, and ROW standards.
• Experience in conducting lab investigations, writing deviations, implementing CAPA and initiating change control.
• Strong data integrity knowledge and practices.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Proficient in MS Word, Excel, Power Point and other applications
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.

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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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