Senior Biologics Manufacturing Technical Expert

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
 

Are you ready to lead Gilead’s next chapter as we design and establish our biologics manufacturing footprint in Foster City, CA? 

Gilead Sciences is seeking exceptional, hands-on technical experts in Biologics Drug Substance Single-Use GMP Manufacturing who thrive at the intersection of strategy, technical innovation, and real-world execution. 

In this role, you will own and directly execute critical elements of the design, startup, and operation of a new, state-of-the-art Single Use DS Biologics Manufacturing facility in Foster City. This is a rare opportunity to help build a facility from the ground up—while also being on the floor ensuring the solutions you develop truly work. This role is intentionally designed as a hybrid technical and execution role, with presence on the manufacturing floor to directly impact operations and continuously translate real‑world experience into improved processes, documentation, and strategy. 

This highly dynamic role requires: 

• Deep technical experience across biologics DS operations and single‑use technologies 

• A builder’s mindset—comfortable shifting between long‑range strategy and detailed, hands‑on execution 

• Collaboration across cross‑functional project, engineering, Quality, and operations teams 

• Adaptability and ownership, with a willingness to take on whatever is needed to successfully start up and run a new facility 

• Integrity, commitment to cGMP compliance, and a commitment to always act in the best interests of our patients 

You will alternate seamlessly between strategic design decisions (facility, equipment, documentation, manufacturing strategy) and hands-on GMP execution during startup and ongoing operations. This role is ideal for technical experts who want to both architect the future, actively bring it to life, and support its ongoing operation. 

We’re seeking trailblazers—collaborative, action‑oriented technical experts who are energized by complex problems, motivated by building new capabilities, and driven to leave a legacy through their solutions and the knowledge they share. 

Key Responsibilities:

As a key technology and operations expert, you will shape the design of Gilead’s new Foster City Biologics Drug Substance manufacturing plant and then start up and operate the plant for ongoing cGMP manufacturing. Your responsibilities will include:  

Manufacturing Execution and Startup Ownership   

• Support first time execution readiness for unit operations, systems, and workflows. Perform dry runs, engineering runs, and end-to-end execution walkthroughs to identify gaps prior to GMP go-live. 

• Act as a technical first responder during campaigns to stabilize operations and resolve issues in real time. 

• Directly execute and document key operations on the plant floor in full compliance with cGMP expectations. 

• Plan and execute full‑scale process and equipment validation studies. 

• Stay current on industry best practices in single‑use biologics manufacturing and champion adoption within Gilead. 

GMP Facility Startup and Equipment/Process Design Input 

• Provide manufacturing end-user input to facility, equipment, and automation design decisions. 

• Support implementation and manufacturing workflow development for the startup of digital manufacturing and data solutions in collaboration with automation, engineering, and information technology teams. 

• Participate in and support risk assessments and startup readiness activities for new equipment, processes, and workflows. 

• Partner with Technical Development to provide manufacturability input on process platforms, and translate new process requirements into equipment, automation, and documentation updates. 

Operational Excellence, Digital Innovation, and Cross-Functional Leadership 

• Develop innovative, intuitive, and pragmatic solutions to complex technical challenges. 

• Identify and implement process improvements to increase yield, optimize capacity, improve operational efficiency, reduce cost, enhance compliance, and ensure safety 

• Compliantly apply AI tools to enhance productivity for yourself and the team. Identify opportunities to develop specialized AI tools and digital manufacturing solutions within your area of technical expertise. 

• Represent Foster City Manufacturing as a member of cross-functional project teams providing guidance, insight, and recommendations. 

• Serve as a consultant to senior management and act as an external spokesperson for the organization on technical matters 

• Model inclusive, transparent decision-making, combining diversity in thought and perspective with consistency and clarity in accountability 

• Exemplify Gilead’s Core Values—integrity, inclusion, teamwork, excellence, accountability. 

• Demonstrate the Gilead Leadership Commitments as a visible technical leader: I AM BOLD, I CARE, I LISTEN, I TRUST, and I OWN. 

GMP Documentation, Quality, and Compliance 

• Translate process design and engineering documentation into clear, executable operational SOPs, work instructions based on hands-on execution during startup. 

• Author and review GMP documentation (SOPs, work instructions, batch records, automation recipes, training materials, validation protocols/reports). 

• Initiate, investigate, resolve, and support CAPAs for GMP deviations within your areas of expertise. 

• Support Quality Risk Management (QRM) activities, ensuring balanced and science‑based Quality and Compliance decisions. 

• Interact with health authorities as a Subject Matter Expert and area representative during site inspections and through written regulatory submissions 

Characteristics for Success 

Creativity: Apply your expert knowledge to design simple, intuitive, and scalable solutions for the facility, equipment, and operational practices. 

Leadership: Lead by example. Share knowledge broadly, challenge the status quo with constructive, forward‑looking ideas, and mentor the next generation of subject matter experts. 

Collaboration: Build alliances across functions with an Enterprise‑First mindset. Embrace constructive debate as an opportunity to improve outcomes and approach differing viewpoints with curiosity and respect. 

Curiosity: Exhibit a passion for exploring new ideas and diverse perspectives, an appreciation for the value of learning through experimentation, and the courage to share failures in the pursuit of knowledge. 

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