Senior Biologics Manufacturing Technical Expert II

Gilead Sciences • Foster City, CA

12d • Onsite

About The Position

Gilead Sciences is seeking a hands-on technical expert in biologics drug substance single-use GMP manufacturing to help design, establish, start up, and operate a new biologics manufacturing facility in Foster City, California. The role combines strategic facility, equipment, documentation, and manufacturing design with direct execution on the manufacturing floor during startup and ongoing operations. The successful candidate will translate practical manufacturing experience into improved processes, documentation, and strategy while collaborating across project, engineering, Quality, Technical Development, automation, information technology, and operations teams.

The role focuses on bringing a state-of-the-art single-use drug substance facility from design through cGMP manufacturing. It includes first-time execution readiness, engineering and validation activities, real-time technical support during campaigns, GMP documentation and compliance, operational excellence, and digital manufacturing innovation. The position also provides technical leadership, coaching, and mentorship, and may include management responsibilities in addition to technical leadership and matrix team management.

Gilead describes its culture as committed to integrity, inclusion, teamwork, excellence, and accountability, and aims to foster an inclusive workplace. The position is based in Foster City, California. The salary range is $169,320 to $219,120, with potential eligibility for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and company-sponsored medical, dental, vision, and life insurance plans.

Requirements

• Recognized industry expertise in biologics drug substance single-use manufacturing.
• BS, MS, or PhD degree in Science or Engineering.
• At least 8 years of deep technical experience in biologics drug substance manufacturing, along with breadth of applied industry experience.
• Applicants are not expected to have deep experience in every listed technical area; the team is intended to bring complementary skills and experience.
• On-the-floor experience as a plant technician and/or front-line supervisor in a licensed biologics drug substance manufacturing facility using single-use technologies.
• Experience with design, commissioning and qualification, validation, and operational startup of cGMP biologics manufacturing facilities, utilities, process equipment, and analytical equipment.
• Experience with single-use technology systems, including equipment and consumables engineering design, selection, use, and performance trending for cGMP biologics manufacturing.
• Experience designing and practically applying risk-based cGMP controls for processes, equipment, facilities, and documentation, including Contamination Control Strategy.
• Experience with CHO-based biologics drug substance process design, development, process validation, and technology transfer from lab or pilot plant to manufacturing production floor and/or between manufacturing sites, from cell banking through formulated drug substance.
• Experience with process automation, controls engineering, manufacturing data management, MES, and ERP recipe design and use.
• Experience with digital manufacturing process design, digital lifecycle management, process parameterization, and digital technology transfer.
• Practical experience applying AI and advanced digital solutions to deliver business value, measurable efficiency, and improved employee engagement or satisfaction in pharmaceutical manufacturing operations.
• Experience in cGMP biologics manufacturing Quality Assurance, Quality Risk Management, plant-floor Quality oversight, and/or Quality auditing.
• Experience with manufacturing optimization, operational excellence, and continuous improvement while meeting quality, compliance, and risk-management objectives.
• Experience developing human proficiency for GMP activities, including training, learning, skills augmentation and assessment, content design and delivery, and proficiency monitoring.
• Knowledge of FDA, EMA, and ICH requirements and inspections for cGMP biologics manufacturing, including expectations for clinical and commercial manufacturing controls.
• People leadership and management experience, including recruitment and development, communication and difficult employee conversations, high-performing team building, organizational culture, and team engagement.

Nice To Haves

• Experience with Emerson DeltaV, PI, Inductive Automation Ignition, Körber PAS-X, and SAP.

Responsibilities

• Support first-time execution readiness for unit operations, systems, and workflows.
• Conduct dry runs, engineering runs, and end-to-end execution walkthroughs to identify gaps before GMP go-live.
• Act as a technical first responder during manufacturing campaigns to stabilize operations and resolve issues in real time.
• Directly execute and document key plant-floor operations in compliance with cGMP expectations.
• Develop, plan, and execute full-scale process and equipment validation studies.
• Stay current on single-use biologics manufacturing best practices and champion their adoption.
• Provide manufacturing end-user input into facility, equipment, and automation design decisions.
• Support implementation and manufacturing workflow development for digital manufacturing and data solutions 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 process requirements into equipment, automation, and documentation updates.
• Develop pragmatic solutions to complex technical challenges and implement improvements to yield, capacity, efficiency, cost, compliance, and safety.
• Apply AI tools compliantly to improve individual and team productivity and identify opportunities for specialized AI tools and digital manufacturing solutions.
• Represent Foster City Manufacturing on cross-functional project teams, providing guidance, recommendations, and decisions.
• Advise senior management and act as an external spokesperson on significant technical and business matters.
• Translate process design and engineering documentation into executable operational SOPs and work instructions based on hands-on startup execution.
• Author, review, and approve GMP documentation, including SOPs, work instructions, batch records, automation recipes, training materials, and validation protocols and reports.
• Initiate, investigate, resolve, and drive CAPAs for GMP deviations within areas of expertise.
• Lead and participate in Quality Risk Management activities and support balanced, science-based Quality and Compliance decisions.
• Interact with health authorities as a subject matter expert and area representative during site inspections and in written regulatory submissions.
• Provide technical leadership, coaching, and mentorship to less experienced team members.
• Model inclusive and transparent decision-making, share knowledge, and demonstrate Gilead’s leadership commitments and core values.
• Potentially take on management responsibilities in addition to technical leadership and matrix team management.

Benefits

• Potential eligibility for a discretionary annual bonus.
• Potential eligibility for discretionary stock-based long-term incentives; eligibility may vary by role.
• Paid time off.
• Company-sponsored medical insurance.
• Company-sponsored dental insurance.
• Company-sponsored vision insurance.
• Company-sponsored life insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior