Manufacturing Engineer III - Viral Vector Downstream Formulation United States - California - Santa Monica Process/Product Development & Operations Regular Job Description Kite is seeking a Manufacturing Engineer to support Viral Vector Clinical Operations at the Santa Monica facility in Southern California. We are seeking motivated, team-oriented candidates to join a fast-paced team of scientists and engineers to conduct operations related to viral vector purification and formulation. 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 in a team to primarily support downstream and formulation operations for clinical viral vector production at scale with cross training into upstream production activities. Safety and Compliance are the two primary objectives of manufacturing operations. Expected duties include the planning, execution and oversight of safe, compliant and efficient operation of area processes. Responsible for day-to-day planning and execution of all Downstream 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. Works in conjunction with other manufacturing engineers under the guidance of the team Lead. Perform downstream unit operations and operate related equipment such as: Harvest depth filtration, column chromatography, sterile filtration, UFDF, Final fill, and buffer preparation in small scale and pilot scale. Proficiency and routine maintenance of auxiliary equipment including but not limited to: pH/conductivity meters, filter integrity testers, autoclave, peristaltic pumps, tubing welders and analytical equipment to support and monitor the process is required. Perform aseptic operations in a Biological Safety Cabinet. 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 completes all required paperwork using GDPs in a timely and accurate manner. Interacts with scientists, engineers, production staff and operational lead. Ensures that work is performed in accordance with quality standards and SOPs. May support deviation investigations, corrective action implementation and change management initiation. 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 takes initiative in resolving issues. Basic Qualifications: Masters degree and 3+ years of relevant industry experience Bachelors degree and 5+ years of relevant industry experience HS diploma and 9+ years of relevant industry experience Preferred Qualifications: Prior experience in a cGMP-related industry is required, within Biopharmaceutical industry Aseptic processing experience. Experience with downstream unit operations and related equipment listed in the Responsibilities Section. Previous biotechnology experience in viral vector production or downstream manufacturing of monoclonal antibodies in a clinical or commercial environment. Knowledge of Current Good Manufacturing Practices (cGMPs). Prior experience initiating, owning and closing out deviations, change control, CAPA’s and safety improvement projects. Prior experience creating and/or revising SOPs to support projects or continuous improvement objectives. Background or understanding of Lean concepts (5S, KanBan) Background in disposable technology and multi-product facility requirements Able to lift equipment up to 25 lbs. The salary range for this position is: $115,260.00 - $149,160.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. For additional benefits information, visit: Gilead Benefits 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 . For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex , age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. For Current Kite Pharma Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday. Job Requisition ID R0044856 Full Time/Part Time Full-Time Job Level Associate

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