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Santa Monica, California, United States
Hybrid
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.
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.
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
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
Kite Pharma 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
Please apply via the Internal Career Opportunities portal in Workday.