Biologics Manufacturing Technical Expert III position at Gilead Sciences.| United States of America

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Gilead Sciences Biologics Manufacturing Technical Expert III

Experience: Highly Experienced

Pattern: Full time

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Associate

United States ..........United States of America

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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 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 within 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 design decisions (facility, equipment, documentation, manufacturing strategy) and tactical 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, 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. 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 include 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 costs, 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. Act as an internal spokesperson for the organization in your area(s) of technical expertise 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. 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, and support CAPAs for GMP deviations within your areas of expertise. Participate in Quality Risk Management (QRM) activities, ensuring balanced and science‑based Quality and Compliance decisions. Support health authority interactions during site inspections and regulatory submissions Characteristics for Success Creativity : Apply your expert knowledge to design simple, intuitive, and scalable solutions for the facility, equipment, and operational practices. 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. Share knowledge broadly, challenge the status quo with constructive, forward‑looking ideas 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: BS with at least 5 years of applied industry experience Applied experience across at least two 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 all the below 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 candidate’s 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, commission/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 to 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 The salary range for this position is: $126,820.00 - $164,120.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. 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. For jobs in the United States: 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 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 Gilead Sciences 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. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.

Biologics Manufacturing Technical Expert III job opportunity at Gilead Sciences.

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