Quality Control | Santa Monica, CA | Full Time
Kite Pharma, Inc. is focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to eradicate cancer cells. We believe our immunotherapy is a market-redefining approach to the treatment of cancer. We are an innovative and growing company located in beautiful Santa Monica and have a highly energized and accomplished team. We had one of the most successful biotechnology IPOs in 2014 and have a current market capitalization of well over $2.5 billion (NASDAQ: KITE).
Kite is seeking a highly motivated Microbiologist to work on innovative T cell therapy for cancer treatment. You will perform sterility testing and environmental monitoring testing of clinical manufacturing of final drug product. Additionally, you will stage appropriate validation of microbiological methods for cell therapy products including rapid release methods. Responsible for environmental monitoring, raw material testing, in-process and final product testing and method qualification as required.
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
- Work with internal and external resources to maintain lab in an optimal state
- Assist with 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 and develop in-process and final specification system for drug substance and drug product of Kite cell therapy product
- Monitor and trend data
- Assemble reports on findings from environmental monitoring of Kite’s cGMP facility, frequently update management on environmental trends and 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. Interact with agents from Regulatory agencies and participate in Pre-Approval Inspections
- Develop, revise and review SOPs, qualification/validation protocols and reports
- Assist in investigations regarding out of specifications (OOS) results, address and manage deviations related to micro procedures and 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
- Perform other duties as required
- Bachelors degree in Microbiology preferred with 8-10 years of microbiology lab experience or MS with 5-7 years of microbiology lab experience in the biotech and/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 products
- 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
- Working knowledge of aseptic manufacturing and EM processes
- Equipment and utility IQ/OQ/PQ/PV
- Proficient in MS Word, Excel, Power Point and other applications
- Ability to communicate and work independently with scientific/technical personnel.
- Ability to think critically, and demonstrated troubleshooting and problem solving skills
- Self-motivated and willing to accept temporary responsibilities outside of initial job description
- 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.