Manager, QC Microbiology - United States
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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.
We are seeking a highly motivated individual to join us as a QC Microbiology Manager in our new commercial cell therapy production center located in El Segundo CA. 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 QC Associate Director of Microbiology. In this role you will be responsible for the day to day oversight of the QC Microbiology team and Sample Management team. You will also be responsible for environmental monitoring program, raw material testing, final product testing and sample management program.
Responsibilities (include but are not limited to):
- Supervision of all QC Micro laboratory testing
- Supervision of sample receipt, retain storage and disposal
- Sustain environmental monitoring program for Kite
- Management and optimization of the Aseptic gowning training and qualification program
- Management of QC Microbiology training program
- Work with QC raw materials team to establish specifications and testing process of raw materials
- 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
- 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, 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
- Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team based environment.
- A minimum of 10 years’ experience working in the Environmental Monitoring and Microbiology laboratories in an aseptic sterile manufacturing facility is required. A minimum of 3 years’ experience supervising/managing microbiology and environmental monitoring labs 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
- The incumbent will need to have the ability to gown for entry into Aseptic core and supporting areas, on an as-needed
- 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.
- Identifying, writing evaluating and closing OOS’s and investigations
- Strong knowledge of contamination control, disinfection, cleanroom design and operation, aseptic techniques
- 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
- Flexibility to work weekends/overtime as needed
- Must be capable of bending, lifting, moving and/or carrying up to approximately 25 pounds
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 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. 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.