Quality Control Microbiology - Manager, Quality ControlUnited States - California - San DiegoQualityRegular
Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work.
We are seeking a highly motivated individual to join us as a Manager, Quality Control in our new viral vector manufacturing facility located in Oceanside, CA.
- Oversees execution of final product release testing including EM, raw material/growth promotion testing and water testing.
- Complete routine record review and approval of test data and related documents for inprocess testing, utility monitoring and drug substance/drug product release. i.e. lot report and CofA.
- Accountable for the management of the EM programs including monitoring and trending data in LIMS.
- Establish user requirements for purchase, qualification of Kite’s QC microbiology equipment.
- Work with internal and external resources to maintain equipment in an optimal and compliant state.
- Responsible for the QC Microbiology and Aseptic Techniques Training programs.
- Manage and conduct lab investigations regarding out of specifications (OOS) results and EM excursions. Address and manage agile records related to microbiology operations/EM program for timely closure.
- Author and own Agile records including deviation, CAPA, EV, and change controls.
- Evaluate and implement continuous improvement initiatives.
- Develop, revise and review SOPs, qualification/validation protocols and reports.
- Ensures adherence to department, site and corporate SOPs and other regulatory requirements for lab readiness for audit.
- Interact with inspectors as Microbiology SME and participate in internal, corporate and QP inspections.
- Assist in the preparation of data packages for interactions between Kite and regulatory agencies.
- Responsible for ensuring QC Microbiology training is complete in timely manner to meet business requirements and ensure compliance with documented policies/SOP.
- Responsible for data trending, control charts and metrics for final product testing as well as routine micro operations.
- Support cross site projects as needed including tech transfer activities.
- Up to 10% domestic travel.
Master’s Degree and 4+ years’ experience in the application of microbiological techniques
Bachelor’s Degree and 6+ years’ experience in the application of microbiological techniques
High School Degree and 10+ years’ experience in the application of microbiological techniques
- Demonstrated leadership and management skills, including establishing direction and goals, and building good work ethics for the team
- Minimum of 7 years’ experience working in the Environmental Monitoring and Microbiology laboratories in an aseptic sterile manufacturing facility is preferred.
- Minimum of 2 years’ experience supervising/managing microbiology and environmental monitoring labs within the biotechnology or pharmaceutical industry
- Experience in the application of microbiological techniques such as air monitoring, water testing, surface monitoring, genus and species identification of various microbes, endotoxin testing and sterility testing of final product.
- Candidate should be well versed in various microbiological techniques including rapid release methods, and qualifying environmental monitoring processes with reference to cell therapy product