Manufacturing Engineer III- Viral Vector Clinical Operations

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. Job Description Kite is seeking a Manufacturing Engineer III to support Viral Vector Clinical Operations at the Santa Monica facility in Southern California. This Individual will help coordinate logistics and operations related to day-to-day activities of at-scale production of the viral vectors in the clinical GMP pilot facility. Join a team of manufacturing engineers supporting routine to complex assignments following established Standard Operating Procedures (SOPs), Master Batch Records and current Good Manufacturing Practices (cGMPs). Responsibilities (include but not limited to): Work within a team of manufacturing engineers to support end to end operations for clinical viral vector production at pilot and bench scale with a primary focus on upstream production. Partner with EHS to promote positive safety culture and ensure facility and operations are maintained at the highest level of safety. Provide purposeful presence in the production suite to ensure compliant and efficient operation of area processes. Responsible for planning and execution of upstream production operations as well as all related equipment and systems necessary to clean, configure, sanitize/sterilize and maintain equipment in a dynamic and fast-paced team environment. Coordinate with downstream engineers to develop training plan and team responsibility matrix. Perform upstream unit operations and operate related equipment such as: Vial thaw, shake flask, pooling operations within proper aseptic technique in a biosafety cabinet, and single use bioreactor units. Proficiency and routine maintenance of auxiliary equipment including but not limited to: cell counters, pH/conductivity meters, filter integrity testers, autoclave, peristaltic pumps, tubing welders and analytical equipment to support and monitor the process is required. Development of chromatography methods to enable column chromatography operations. Create and revise SOPs to support CAPAs, capital projects, and continuous improvement objectives. Good Documentation Practices (GDPs), timely and effective written and oral communication of deviations, incidents, and/or safety concerns, and all relevant housekeeping duties to ensure the work areas are kept to a high level of cleanliness and inspection readiness. Set up and operate equipment in a ISO-7/ISO-5 clean room environment and complete all required paperwork using GDPs in a timely and accurate manner. Interact with scientists, engineers, production staff and operations director. Ensures that work is performed in accordance with EHS, quality, and operational standards and SOPs. Support deviation investigations, corrective action implementation. In-depth knowledge of quality systems, validation principles, regulatory/ICH guidelines and multi-product controls preferred. Departmental representation as an SME (Subject Matter Expert) on cross-functional teams including Process Development, Quality Assurance and Control, Calibration, Maintenance, Validation, Supply Chain, and CMC/Regulatory teams is required. Perform troubleshooting as necessary and take initiative in resolving issues. Develop bill of materials and manage raw material planning and inventory for GMP and non GMP orders. Analyze data and provide recommendations on process improvements. Basic Qualifications: Master’s degree in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent and 3+ years of relevant industry experience OR Bachelor’s degree in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent and 5+ years of relevant industry experience OR HS diploma and 9+ years of relevant industry experience in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent Preferred Qualifications: Bachelor’s degree in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent and 5+ years of relevant industry experience Prior experience in a cGMP-related industry is required, within Biopharmaceutical industry Aseptic processing experience. Experience with upstream unit operations and related equipment