Sr Manager, Process Engineering
PharmaBiotechRegulatory AffairsQuality Assurancegmpcroinformaws
Job description
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 The Manufacturing Science and Technology (MSAT) Operations & Automation Technology (OAT) Manager / Senior Manager serves as a technical leader supporting clinical cell therapy manufacturing operations. This role partners with Manufacturing, Facilities & Engineering, Quality, Validation, IT, Process Development, and Network MSAT to ensure reliable operation of manufacturing equipment, automation platforms, computerized systems, and data-integrity compliant processes. The position provides technical support for GMP manufacturing, technology transfers, new product introductions, equipment lifecycle management, automation initiatives, deviation investigations, change controls, and continuous improvement projects. The engineer acts as a key interface between manufacturing operations and technology functions to drive operational excellence, scalability, and innovation. Kite is transitioning from its current Santa Monica headquarters, with employees expected to relocate to either our El Segundo or Thousand Oaks offices beginning in January 2027. While this role will be based in Santa Monica through 2026, applicants should take this planned relocation into consideration. Kite supports a flexible working policy, offering a balanced approach with two days of remote working and three days working onsite. Key Responsibilities Equipment and Automation Support Provide technical support for GMP manufacturing equipment and automation systems. Lead or support equipment troubleshooting, root-cause investigations, and implementation of corrective actions. Support equipment upgrades, software updates, and introduction of new technologies. Coordinate with Facilities & Engineering, Validation, IT, and vendors to maintain system reliability. Serve as technical SME for assigned manufacturing systems and automation platforms. Technology Transfer and New Product Introduction Support clinical manufacturing technology transfers and process introductions. Assess equipment readiness, automation requirements, and system impacts associated with new programs. Partner with cross-functional teams to ensure successful implementation of manufacturing processes. Develop and execute equipment-related readiness plans for new products and process changes. Manufacturing Operations Support Provide technical support during manufacturing campaigns. Participate in lot monitoring, escalation management, and rapid issue resolution. Evaluate process and equipment performance trends and identify improvement opportunities. Support manufacturing readiness activities, batch execution success, and operational reliability. Quality Systems and Compliance Author and review deviations, CAPAs, change controls, risk assessments, and technical reports. Support impact assessments associated with equipment, automation, and process changes. Ensure activities comply with GMP, data integrity, and regulatory requirements. Support audit and inspection readiness activities. Continuous Improvement and Data Analytics Drive equipment and automation improvements that increase process robustness and operational efficiency. Implement data collection, trending, monitoring, and visualization tools to improve manufacturing performance. Evaluate emerging technologies, digital tools, AI solutions, and automation opportunities for clinical manufacturing. Support development of dashboards and systems that improve operational visibility and decision making. Success Measures Reliable support of manufacturing operations with minimal equipment-related disruptions. Timely execution of equipment upgrades and automation deployments. Successful support of tech transfers and new product introductions. High-quality investigation, CAPA, and change-control execution. Implementation of technology and process improvements that enhance operational efficiency and scalability. Basic Qualifications: Bachelor's Degree and Eight Years' Experience OR Masters' Degree and Six Years' Experience OR PhD / PharmD Preferred Qualifications: Experience in facilities, engineering in a biotech/pharma industry Degree in Engineering, Biotechnology, Life Sciences, Computer Science, or related field. Experience supporting GMP manufacturing operations, automation systems, or process engineering. Knowledge of biologics, cell therapy, gene therapy, or pharmaceutical manufacturing. Experience with investigations, change controls, and quality systems. Strong technical writing and cross-functional collaboration skills. 10+ years of relevant experience supporting cell therapy manufacturing operations. Experience with MES, EBR, SCADA, PLC, data historians (OSI PI, Chronicle, CellFactory), or manufacturing automation systems. Knowledge of qualification and validation requirements. Experience leading technology transfers or equipment implementation projects. Familiarity with computerized system lifecycle management and data integrity requirements. Proficiency in application of AI-based solutions and data analytics in manufacturing environments. Experience leading direct reports and developing and mentoring staff People Leader Accountabilities: Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving feedback and insight needed to grow, develop and realize their purpose. Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem The salary range for this position is: $153,935.00 - $199,210.00. Kite considers a variety of factors when determining base
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