QC Microbiology Manager
Quality Control | Santa Monica, CA | Full Time
Kite Pharma Inc, founded in 2009, is dedicated to the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to fight tumor cells. We are a dynamic and accomplished team with an exciting growth trajectory for the coming year.
We are seeking a highly motivated individual to join us as the QC Microbiology Manager. You will work with the Quality Control team in supporting our efforts in this exciting new area of cancer immunotherapy. This role will be a hands-on resource reporting to the Director of QC. In this role you will perform sterility testing and environmental monitoring testing of clinical manufacturing of final drug product and stage appropriate validation of microbiological methods for cell therapy products including rapid release methods. You will also be responsible for environmental monitoring, raw material testing, in-process and final product testing as well as purchasing, installing and qualifying required instrumentation. You will provide oversight of CMO and testing labs regarding microbiological processes.
Responsibilities (include but are not limited to):
- Perform sterility testing of in-process and final product per compendial methods
- Establish, validate and sustain environmental monitoring program for Kite
- Establish user requirements for purchase, qualification of Kite’s QC microbiological equipment and work with internal and external resources to maintain equipment in an optimal state
- Manage the validation of rapid release microbiological methods in QC as well as the transfer and validation of methods to a contract-testing lab (validation of methods will be phase appropriate)
- Establish specifications and testing process of raw materials. Develop in-process and final specification system for drug substance and drug product of Kite cell therapy product
- SME on investigations of sterility and environmental excursions
- Monitor and trend data
- Assemble reports on findings from environmental monitoring of Kite’s cGMP facility. Frequently update management on environmental trends. Implement corrective action plans when necessary
- CMO and OTL tracking to complete lot disposition
- 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
- Assist in the preparation of dossiers and data packages for interactions between Kite and Regulatory agencies and interact with agents from Regulatory agencies and participate in Pre-Approval Inspections
- 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
- Bachelor's degree or advanced degree in Microbiology or related discipline
- At least eight years of managing microbiology lab experience with a BS or five years of microbiology lab experience with a MS within the biotechnology or pharmaceutical industry
- 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
- 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
- Identifying, writing evaluating and closing OOS’s and investigations
- Strong knowledge of aseptic manufacturing and EM processes
- Equipment and utility IQ/OQ/PQ/PV
- 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, an equal opportunity employer, is located in beautiful Santa Monica, CA just steps from Santa Monica Blvd and right off the 10. We are able to offer the opportunity to be part of the first 100 employees in this successful, fast growing company. A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation. Did we forget to mention the stock options? To learn more about us, please visit our website at www.kitepharma.com.
If you are interested in applying for this opportunity, please submit your resume or CV, cover letter and salary requirements. All submissions will be evaluated and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.
No phone calls please and no agencies or recruiters.