Head of Process Automation, Foster City Biologics Manufacturing

Job description

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. 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 Gilead and help create possible, together. Job Description At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As the Head of Process Automation, Foster City Biologics Manufacturing, you will hold a key leadership role accountable for defining and executing the site process automation strategy, operating model, governance, and lifecycle roadmap for DeltaV-based process equipment automation supporting the Foster City Manufacturing New Chess Facility (NCF) and the biologics Pilot Plant within the New Technical Development Center (NTDC). This role will lead a high-performing organization of internal engineers and specialized contract resources through design, startup, qualification, operational readiness, and steady-state lifecycle support while ensuring alignment with manufacturing, digital, quality, compliance, and enterprise automation priorities. The position serves as the business owner and technical authority for DeltaV process automation systems supporting GMP and non-GMP biologics drug substance manufacturing, including bioreactors, chromatography systems, TFF, filtration, harvest, buffer/media preparation, and associated batch execution capabilities. The role will work closely with pilot and GMP Manufacturing, MSAT, Corporate Operations Automation, Engineering, Validation, Quality, IT, Tech Dev, and equipment vendors to create a robust, agile, scalable, and compliant automation ecosystem. Job Responsibilities: NCF and NTDC Automation Strategy & Delivery Serve as the site DeltaV process automation owner for NCF and NTDC from detailed design through operational readiness and ongoing production. Define and execute the automation roadmap for DeltaV process control systems. Collaborate closely with IT and Corporate Operations Automation to establish the Foster City biologics pilot and manufacturing facilities as industry leading digital biologics facilities - integrating DeltaV, MES, Process Parameter management, BAS, ERP, LIMS, Historian and analytics platforms. Establish site process automation standards, governance, and lifecycle management processes.​ Ensure alignment with manufacturing objectives, digital manufacturing strategy, and future facility expansion plans. ​Represent process automation on site governance, project steering, startup, and operational readiness teams. ​Partner across Gilead and Kite to develop a vision, roadmap, and implementation strategy for compliant and responsible use of AI in manufacturing automation. DeltaV System Ownership Own the DeltaV platform supporting GMP and non-GMP process equipment in Foster City across the biologics manufacturing process. Oversee system architecture, configuration standards, batch control strategy, alarm philosophy, historian integration, and recipe governance. Ensure systems maintain validated status and comply with applicable GxP, data integrity, and cybersecurity requirements. Lead lifecycle management activities including upgrades, patching, obsolescence planning, backup/recovery, and disaster recovery readiness. Establish a standardized and reusable DeltaV code base to support long-term scalability and supportability. Organization Building & Leadership Build, lead, and scale a fit-for-purpose process automation organization consisting of internal employees, matrixed partners, and contract resources, with clear roles, decision rights, technical capability expectations, and accountability for delivery, operational support, and lifecycle ownership. Develop a sustainable support model for startup and steady-state operations. Define and implement a sustainable support model for startup and steady-state operations, including escalation coverage, vendor and contractor interfaces, knowledge management, service levels, and coordination with the Corporate Operations Automation organization. Recruit, mentor, coach, develop, and retain automation engineers and technical specialists while building a leadership pipeline and promoting differentiated career growth for high-performing technical talent. Foster a culture of technical excellence, ownership, reliability, safety, compliance, and continuous improvement. Project Execution (NTDC and NCF) Accountable for site process automation deliverables for design reviews, FATs, SATs, commissioning, qualification, and startup. Work with an enterprise mindset to ensure project deliverables meet schedule, cost, quality, and compliance objectives. Drive timely issue resolution during facility construction, startup, and GMP operations. Support technology transfer and process implementation activities alongside MSAT, Tech Dev, and Manufacturing. Operational Support Establish procedures and governance for automation incident management, change control, deviation support, and CAPA execution. Lead troubleshooting of complex automation and batch execution issues. Partner with Operations to maximize system availability, reliability, and manufacturing throughput. Develop site automation KPIs and reliability metrics. Manage system integrators, automation contractors, OEMs, and engineering partners. Serve as escalation point for critical automation-related production events. Compliance & Cybersecurity Ensure compliance with GxP, 21 CFR Part 11, Annex 11, data integrity requirements, and corporate quality standards as applicable. Lead OT cybersecurity activities for process automation systems in partnership with IT and cybersecurity organizations. Support inspections, audits, and regulatory interactions related to automation systems. Requirements: Bachelor's degree in Engineering, Automation, Chemical Engineering, Electrical Engineering, Computer Engineering, or related technical discipline with 10+ years of relevant experience (defined below) required OR Masters degree in Engineering, Automation, Chemical Engineering, Electrical Engineering, Computer Engineering, or related technical discipline with 8+ years of relevant experience (defined below) OR PhD in Engineering, Automation, Chemical Engineering, Electrical Engineering, Computer Engineering, or related technical discipline with 5+ years of relevant experience (defined below) Relevant experience: direct, matrixed, or cross-functional leadership experience, including experience building teams, leading technical managers or senior individual contributors, managing external partners, and influencing senior stakeholders in a regulated manufacturing env