Head of Process Automation, Foster City Biologics Manufacturing

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 environment.

• Relevant experience: automation, process control, or manufacturing systems experience in biopharmaceutical, biotechnology, or regulated manufacturing environments, including extensive experience with DeltaV-based GMP manufacturing automation and lifecycle ownership.

Preferred Qualifications:

• Advanced degree preferred

Technical Expertise

• Deep knowledge of Emerson DeltaV, with the ability to set technical direction, challenge design decisions, assess risk, and guide expert engineers and integrators.

• Expert knowledge of batch automation and ISA-88 principles.

• Experience supporting biologics Drug Substance manufacturing processes.

• Experience with GMP validation and computerized systems compliance.

• Knowledge of historian systems, automation networking, industrial cybersecurity, and OT infrastructure.

• Experience with large capital projects, facility startup, and operational readiness activities.

• Up-to-date knowledge of industry developments and best practices in automation, OT, digital manufacturing, and manufacturing systems integration.

Demonstrated Leadership Capabilities

• Building teams and organizational capabilities from the ground up.

• Strong collaboration, stakeholder management, and influencing skills.

• Ability to balance strategic planning with hands-on technical problem solving.

• Ability to lead through ambiguity and startup environments.

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 the 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.

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. 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 [email protected] for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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