Hiring company: Kite Pharma
We are seeking a highly motivated individual to join us as a Lab Ops Specialist I. This position provides Quality Control testing of clinical and commercial product, responsible for raw material testing, in-process and final product testing.
Responsibilities:
- Perform and review testing of raw materials, intermediates and final products by following analytical methods. Enter results into GMP systems.
- Maintain, calibrate and operate equipment and instruments supporting cell bioassays, Flow Cytometry, ELISA, qPCR and ddPCR assays.
- Track and test products according to Stability protocols. Compile and review stability protocols data.
- 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, if needed.
- Revise and review SOPs, qualification/validation protocols and reports.
- If needed, conduct investigations regarding out of specifications (OOS) results. Address and manage deviations related to analytical procedures. Provide updates at daily and weekly meetings.
- Perform on-the-job training and Instructor-Led training for other staffs.
- Monitor the GMP systems currently in place to ensure compliance with documented policies.
- Help review proposed changes to systems, procedures, methods, and submissions to regulatory agencies.
- Gather metric information, analyze and provide recommendation for continuous improvement of areas of responsibility.
- Perform other duties as assigned.
- This position will work day shift Wed-Sat; 6:0am-5:00pm
Basic Qualifications:
- Bachelor’s Degree OR
- AA Degree and 2+ years’ experience in Quality Control OR
- High School Degree and 3+ years’ experience in Quality Control
Preferred Qualifications:
- Degree in biotechnology or related field with Quality Control experience
- Working knowledge of GMP, SOPs and quality control processes
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
- Well versed in one or more analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals
- Proficient in MS Word, Excel, Power Point and other applications
- Ability to communicate and work independently with scientific/technical personnel
- Strong written and verbal communication skills
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
Does this sound like you? If so, apply now!
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.