Senior Biologics Manufacturing Technical Expert II

Job Responsibilities

• 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.
• Develop, 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.
• 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.
• 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, recommendations, and decisions.
• Serve as a consultant and advisor to senior management and act as an external spokesperson for the organization on significant technical and business matters.
• Translate process design and engineering documentation into clear, executable operational SOPs, work instructions based on hands-on execution during startup.
• Author, review, and approve GMP documentation (SOPs, work instructions, batch records, automation recipes, training materials, validation protocols/reports).
• Initiate, investigate, resolve, and drive CAPAs for GMP deviations within your areas of expertise.
• Lead and participate in 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.
• Provide technical leadership, coaching, and mentorship to less experienced team members.

Qualifications

• Recognized industry expert in Biologics Drug Substance Single Use Manufacturing.
• BS, MS, or PhD degree in Science or Engineering with a minimum of 8+ years of deep technical experience in Biologics DS Manufacturing plus breadth of applied industry experience.
• 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.