Associate Scientist, Quality Control (Contract)
Quality | Santa Monica, CA | Contract
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 Associate. This is a 6 month contract to perm opportunity. This position provides Quality Control testing of clinical and commercial product, responsible for raw material testing, in-process and final product testing along with 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.
- 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 Pharma 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.