Senior Biologics Manufacturing Technical Expert

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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 Gileads 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 upwhile 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 realworld experience into improved processes documentation and strategy.

This highly dynamic role requires:

• Deep technical experience across biologics DS operations and singleuse technologies

• A builders mindsetcomfortable shifting between longrange strategy and detailed handson execution

• Collaboration across crossfunctional 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.

Were seeking trailblazerscollaborative actionoriented 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 Gileads 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 fullscale process and equipment validation studies.

• Stay current on industry best practices in singleuse 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 Gileads Core Valuesintegrity 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 sciencebased 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 forwardlooking ideas and mentor the next generation of subject matter experts.

Collaboration: Build alliances across functions with an EnterpriseFirst 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.

Basic Qualifications

• Recognized expert in Biologics Drug Substance Single Use Manufacturing.

• BS degree in Science or Engineering with at least 6 years of technical experience in Biologics DS Manufacturing plus breadth of applied industry experience.

Deep applied experience across at least three of the following technical dimensions coupled with a passion for learning and curiosity to expand and lend a hand across all areas. Please note that each applicant is not expected to have deep experience across every one of the technical areas to be qualified. We are seeking to build a cohesive and high performing team that collaboratively covers this space with a complementary diversity of skills strengths and experience. The ultimate level of the position will depend on the business and technical scope taken on by the successful candidate which will be commensurate with the candidates experience and demonstrated capabilities.

• On-the-floor experience as a plant technician and/or front-line supervisor within a licensed Biologics DS manufacturing facility utilizing Single Use Technologies

• Design commissioning/qualification validation and operational startup of cGMP Biologics manufacturing facility utilities process and analytical equipment

• Single Use Technology (SUT) systems (equipment and consumables) engineering design selection use and performance trending for cGMP Biologics manufacturing

• Design and implementation of risk-based cGMP controls applied to processes equipment facilities and documentation including Contamination Control Strategy design and practical application

• CHO-based Biologics Drug Substance process design development process validation and tech transfer from lab/pilot plant to manufacturing production floor and/or between manufacturing sites from cell banking through formulated DS

• Process automation controls engineering manufacturing data management Manufacturing Execution System (MES) and Enterprise Resource Planning (ERP) recipe design and use (Emerson DeltaV PI Inductive Automation Ignition Korber PAS-X and SAP experience preferred)

• Digital manufacturing process design digital lifecycle management process parameterization and digital tech transfer

• Practical application of AI and advanced digital solutions to generate concrete business value drive measurable efficiency and enhance employee engagement/satisfaction in pharmaceutical manufacturing operations

• cGMP Biologics Manufacturing Quality Assurance application of Quality Risk Management QA plant floor oversight and Quality Auditor experience

• Innovative approaches to manufacturing optimization operational excellence and continuous improvement while achieving quality compliance and risk management objectives

• Human proficiency development for GMP activities including comprehensive proficiency development solutions spanning training learning skills augmentation skills assessment content design integrated content delivery and proficiency monitoring

• Health Authority (HA) requirements (FDA EMA ICH) and inspections associated with cGMP biologics manufacturing including a solid understanding of the expectations for both clinical and commercial manufacturing controls

• People leadership and management including employee recruitment and development effective communication and navigation of difficult employee conversations building and maintaining high performance teams development and reinforcement of organizational culture and team engagement

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

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