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Quality Control Microbiologist, Quality

Quality | Santa Monica, CA | Full Time

Job Description

Kite, a Gilead Company, is a biopharmaceutical company based in Santa Monica, California. Kite is 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. For more information on Kite, please visit www.kitepharma.com.

We are seeking a highly motivated individual to join us as a QC Microbiologist in our cell therapy production center located in Santa Monica.  You will work with the Quality Control team and Manufacturing and  QA  in supporting Kite efforts in this exciting new area of cancer immunotherapy. In this role you will be responsible for day to day routine testing of QC Microbiological assays and Environmental monitoring.  You will also be responsible for raw material testing inspection and testing. 

Responsibilities (include but are not limited to): 

  • Conduct QC Micro laboratory testing  (Sterility, Endotoxin and Gramstain)

  • Handle sample receipt, retain storage and disposal

  • Perform environmental monitoring program for Kite

  • Manage Aseptic gowning training and qualification program

  • Conduct  QC Microbiology training program

  • Work with QC raw materials team to establish specifications and testing process of raw materials. 

  • SME on investigations of Microbiological assays and environmental excursions

  • Monitor and trend data

  • Assemble reports on findings from environmental monitoring of Kite’s cGMP facility. Implement corrective action plans when necessary

  • Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release.

  • Develop, revise and review SOPs, qualification/validation protocols and reports

  • Conduct investigations regarding out of specifications (OOS) results and address and manage deviations related to micro procedures   

  • 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

  • Gather metric information for use in continuous improvement of areas of responsibility

  • Other duties as assigned

Requirements:

  • Bachelor's degree or advanced degree in Microbiology or related discipline

  • A minimum of 5-7 years’ experience working in the Environmental Monitoring and Microbiology laboratories in an aseptic sterile manufacturing facility is required. 

  • The ideal candidate is well versed in various microbiological techniques including rapid release methods, and qualifying environmental monitoring processes with reference to cell therapy product

  • Experience in the application of microbiological techniques such as air monitoring, water testing, surface monitoring, genus and species identification of various microbes

  • The incumbent will need to have the ability to gown for entry into Aseptic core and supporting areas.

  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)

  • Quality Control, GMPs, microbiological method development and validation

  • Strong knowledge of GMP, SOPs and quality control processes

  • Strong data integrity knowledge and practices.

  • Strong knowledge of aseptic manufacturing and EM processes

  • Proficient in MS Word, Excel, Power Point and other applications

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

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

Kite Pharma is an equal opportunity employer based in beautiful Santa Monica, CA.  Kite Pharma offers the opportunity to be part of a successful, fast growing company in a cross functional and collaborative environment. 

To learn more about us, please visit our website at www.kitepharma.com

No phone calls please and no agencies or recruiters.