Your browser cookies must be enabled in order to apply for this job. Please contact support@jobscore.com if you need further instruction on how to do that.

Quality Control Manager

Quality Control | Santa Monica, CA | Full Time

Job Description

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).

The Quality Control (QC) Manager will provide QC oversight of clinical manufacturing of final drug product and stage appropriate validation of bio analytical methods for cell therapy products.  The QC Manager will also be responsible for environmental monitoring, raw material testing, in-process and final product testing as well as for the purchase, installation and qualification of QC instrumentation.  This position will report to the Director of QC and will be based in our headquarters in Santa Monica, CA

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 product
  • 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
  • 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
  • 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
  • Perform other duties as assigned
  • Travel may be up to 15%

Requirements:

  • PhD molecular biologist or biochemist preferred with at least 7 years of Quality Control experience or MS degree with at least 10 years of Quality Control experience
  • At least 2 years of QC lab management 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
  • Working knowledge of 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)
  • Experience in the medical and/or pharmaceutical industry strongly preferred
  • Proficient in MS Word, Excel, Power Point and other applications
  • Strong written and verbal communication skills, including the ability to communicate and work independently with scientific/technical personnel

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 one year.

No phone calls please and no agencies or recruiters