Scientist, Quality Control - 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 Scientist, Quality Control to provide Quality Control testing of clinical manufacturing of final drug product, to stage appropriate validation of bioanalytical methods for cell therapy products, to be responsible for raw material testing, in-process and final product testing and to manage qualification of QC instrumentation.
Responsibilities (include but are not limited to):
- Perform routine analytical tests for release of Kite Cellular Therapy Products.
- Participate in the transfer and qualification/validation of analytical methods from Analytical Development to QC as well as the transfer and validation of methods to QC Commercial and to 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
- Work with internal and external resources to maintain lab in an optimal state
- 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. 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. Address and manage deviations related to analytical 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
- Perform other duties as required
- Read quality control manuals and testing specifications to obtain data to test or calibrate specific devices
- Select, install and troubleshoot instruments devices
- BS with 6-8 years or MS with 4–6 years of Quality Control experience or PhD molecular biologist or biochemist preferred with 3-4 years of Quality Control experience
- The ideal candidate is well versed in various analytical techniques such as FACS, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, enzyme assays and other applicable methods to the testing of biopharmaceuticals
- Experience in environment monitoring and in investigating the sources of pollution and contamination.
- Experience in Bioreactor/cell Culture Aseptic Techniques
- Experience in Clean Room Operations desirable
- Quality Systems and Auditing Principles
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
- Quality Control, GMPs, bioanalytical method development and validation
- Strong knowledge of GMP, SOPs and quality control processes
- Identifying, writing evaluating and closing OOS’s and investigations
- Equipment and utility IQ/OQ/PQ/PV
- Proficient in MS Word, Excel, Power Point and other applications
- Strong written and verbal communication skills
- Ability to communicate and work independently with scientific/technical personnel
- 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 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.