Scientist, Quality Control - Analytical
Quality | El Segundo, CA | Full Time
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 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.
- 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.
- Required: 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.
- 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 the biotech and/or pharmaceutical industry.
- While most of the schedule will be during a standard work-week, there will be occasional weekend work required.
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.