Senior Microbiologist II, Quality Control - United States
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 QC Sr. Microbiologist in our new commercial cell therapy production center located in El Segundo CA. You will work with the Quality Control team in supporting our efforts in this exciting new area of cancer immunotherapy. This role will be a hands-on resource reporting to the QC Associate Director of Microbiology. In this role you will be responsible for providing Quality Control Technical support to QC and Manufacturing. This is a Monday - Friday 1st shift position.
- Manage the transfer and provide technical oversight of Microbiological methods from Development to QC (validation of methods and tech transfer of methods, including comparability)
- Establish user requirements for purchase, qualification of Kite’s QC equipment and work with internal and external resources to maintain equipment in an optimal state
- Develop, revise and review SOPs, qualification/validation protocols and reports.
- Conduct investigations regarding out of specifications (OOS) results and address and manage deviations related to micro procedures
- 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.
- Train staff on technical concepts and methods
- Review laboratory data
- Perform other duties as assigned.
- Bachelor's degree or advanced degree in Microbiology or related discipline
- A minimum of 8 years’ experience working in a GMP QC Microbiology laboratory, preferably in an aseptic processing facility. A minimum of 3 years’ experience with method and equipment validation within the biotechnology or pharmaceutical industry
- The incumbent will need to have the ability to gown for entry into Aseptic core and supporting areas, and lift approximately 25 lbs.
- The ideal candidate is well versed in various microbiological techniques including rapid release methods (Bac-T, PTS, MCS), and qualifying environmental monitoring processes with reference to cell therapy product
- Strong knowledge of Environmental Monitoring equipment, requirements and tests (viable and non-viable), Aseptic Process Validation, Microbial Identification, and other applicable methods to the testing of biopharmaceuticals
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211/1271, ISO 14644-1, USP, EP)
- Experience in performing risk assessments
- Strong knowledge of Quality Control processes, GMPs, and Microbiological method validation
- Extensive experience in conducting laboratory and environmental excursion investigations.
- Strong knowledge of Equipment IQ/OQ/PQ/PV
- Proficient in MS Word, Excel, Power Point and other applications
- Ability to communicate and work independently with scientific/technical personnel.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description
- Ability to think critically and demonstrate troubleshooting and problem solving skills
- Excellent interpersonal, verbal and written communication skills
- Experience managing projects
- Experience drafting qualification/validation protocols and reports. Experience executing equipment and method qualifications independently.
Kite, a Gilead Company, is an equal opportunity employer based in beautiful Santa Monica, CA. Kite, a Gilead Company, 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.