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Quality Control Scientist, Clinical Quality Control

Quality | Santa Monica, CA | Full Time

Job Description

Kite, a Gilead Company, is a biopharmaceutical company based in Santa Monica, California. Kite is 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. For more information on Kite, please visit www.kitepharma.com.

We are seeking a highly motivated individual to join us as a Quality Control Scientist.  This position provides Quality Control testing of clinical and commercial product, responsible for raw material testing, in-process and final product testing. Qualification of QC instrumentation.

Responsibilities (include but are not limited to):

  • Perform testing of raw materials, intermediates and final products by following analytical methods.
  • Maintain, calibrate and operate equipment and instruments supporting cell bioassays, Flow Cytometry, ELISA and PCR assays.
  • Track and test products according to Stability protocols.
  • Work with internal and external resources to maintain lab in an optimal state.
  • Monitor and trend data, 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.

Requirements:

  • Required:  BS in Medical Technology (minimum of 3 years clinical experience) Bachelor or Master’s degree in biotechnology or related field with 4 – 5 years of Quality Control experience or PhD molecular biologist or biochemist preferred with 1-2 years of Quality Control experience.
  • Strong knowledge of GMP, SOPs and quality control processes.  
  • Identifying, writing, evaluating and closing laboratory (OOS) investigations.
  • 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.
  • The ideal candidate is well versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals.
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211). 
  • Preferred:  Experience in diagnostic testing using flow cytometry, ELISAs in the biotech sector
  • While most of the schedule will be during a standard work-week, there will be occasional weekend work required.

Kite, a Gilead Company is an equal opportunity employer based in beautiful Santa Monica, CA.  Kite Pharma offers the opportunity to be part of a successful, fast growing company in a cross functional and collaborative environment. 

To learn more about us, please visit our website at www.kitepharma.com

No phone calls please and no agencies or recruiters.