Senior Manager of Quality Control
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 billion (NASDAQ: KITE).
We are seeking a highly motivated individual to join us as a Senior Manager of Quality Control (QC). You will work with the QC team in supporting our efforts in this exciting new area of cancer immunotherapy. Under minimal supervision, the successful candidate will be expected to provide QC oversight of the clinical manufacturing of the final drug product. You will also stage appropriate validation of bioanalytical methods for cell therapy products, be responsible for raw material testing, in-process and final product testing. As we are in the process of building out a new commercial manufacturing facility you will be responsible for the purchase, installation and qualification of QC instrumentation. You will report to the Director of Quality Control.
Responsibilities include, but are not limited to:
- Manage the transfer and validation of analytical methods from Analytical Development to 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 products
- Establish user requirements for purchase, qualification of Kite’s QC analytical equipment and work with internal and external resources to maintain equipment in an optimal state
- Manage the department staff and activities, and transfer of fully validated methods to CMO
- Monitor and trend data:
- Assemble reports on product release test monitoring of Kite’s cGMP facility and frequently update management on 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 and generate 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, address and manage deviations related to analytical 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
- Other duties as assigned
- PhD in molecular biology or biochemistry or related discipline with at least 5 years of QC experience or a MS degree in molecular biology or biochemistry or related discipline in the biotech/pharmaceutical industry with at least 10 years of QC experience in the biotech/pharmaceutical industry
- 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
- Responsible for maintaining required cell cultures and qualifying biological reference standards
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
- At least 2 years of QC lab management experience in the biotech and/or pharmaceutical industry
- 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
- Strong knowledge of cell culture techniques
- Equipment IQ/OQ/PQ/PV
- Proficient in MS Word, Excel, Power Point and other applications
- Ability to communicate and work independently with scientific/technical personnel
- Strong organizational and record keeping skills
- Self-motivated and willing to accept temporary responsibilities outside of initial job description
- Experience using both written and verbal communication, including presentations, to communicate results to a diverse cross-functional audience
- 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 200 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.