Scientist, Materials Science

Gilead Sciences•Foster City, CA

1d•$146,540 - $189,640

About The Position

The Scientist, Materials Science provides scientific and technical leadership for the selection, qualification, characterization, and lifecycle management of raw materials, excipients, resins, filters, single-use systems, primary packaging, and other product-contact materials used in biologics development and manufacturing. The role leads phase-appropriate, science- and risk-based material assessments and qualification strategies; supports extractables and leachables, chemical compatibility, supplier changes, investigations, technology transfer, business continuity, regulatory submissions, and inspections; and partners across Technical Development, Manufacturing, Quality, Regulatory Affairs, Supplier Quality, Sourcing, Supply Chain, Analytical Development, and external manufacturing organizations to protect process performance, product quality, patient safety, and supply continuity. The position also plans and interprets material characterization studies, develops robust standards and knowledge-management tools, and communicates clear, evidence-based recommendations to project teams and senior stakeholders.

Requirements

PhD in materials science, chemical engineering, chemistry, biochemistry, pharmaceutical sciences, biotechnology, or a related scientific discipline with 2+ years of relevant experience; or MS with 6+ years; or BS with 8+ years of relevant industry experience.
Experience supporting development, technology transfer, or manufacturing of biologic drug substance or drug product in a regulated biopharmaceutical environment.
Demonstrated expertise with one or more material categories, such as process chemicals, media, excipients, chromatography resins, filters, single-use systems, polymeric components, primary packaging, or manufacturing consumables.
Working knowledge of material characterization, specifications, supplier technical documentation, risk assessment, change management, and GMP expectations.
Demonstrated ability to lead complex technical work independently, manage multiple priorities, and deliver clear recommendations in a cross-functional environment.

Nice To Haves

Advanced knowledge of single-use technologies, polymer science, extractables and leachables, chemical compatibility, filtration, resin performance, injection molding, plastic films, or container-closure systems.
Knowledge of applicable pharmacopeial standards and global regulatory expectations for raw materials, excipients, single-use systems, and product-contact materials.
Experience developing science- and risk-based material control strategies, conducting supplier technical due diligence, and supporting supplier changes, investigations, or alternate-source qualification.
Experience authoring or reviewing technical reports, specifications, validation documentation, and CMC sections for regulatory submissions.
Strong experimental-design, data-analysis, problem-solving, and technical-writing skills, with the ability to translate complex information into practical decisions.
Excellent communication, collaboration, and influencing skills across technical, quality, regulatory, manufacturing, and supply-chain stakeholders.
Demonstrated scientific curiosity, sound judgment, accountability, and commitment to continuous improvement and knowledge sharing.

Responsibilities

Provide scientific and technical leadership for the selection, qualification, characterization, and lifecycle management of raw materials, excipients, resins, filters, single-use systems, primary packaging, and other product-contact materials used in biologics development and manufacturing.
Lead phase-appropriate material risk assessments and define material requirements, critical attributes, specifications, testing strategies, and risk mitigations to protect process performance, product quality, patient safety, and supply continuity.
Drive material qualification activities from identification of need through supplier selection, technical qualification, GMP implementation, and lifecycle monitoring, ensuring complete and inspection-ready documentation.
Lead or support extractables and leachables assessments, chemical compatibility evaluations, supplier-document reviews, and single-use assembly or drawing reviews; author clear risk assessments and technical reports.
Assess supplier-initiated material and process changes using science- and risk-based approaches; define supporting data, studies, and implementation controls proportionate to potential impact.
Partner with Technical Development, MSAT, Manufacturing, Quality, Regulatory Affairs, Global Supplier Quality, Strategic Sourcing, Supply Chain, Analytical Development, and external manufacturing organizations to make evidence-based material and supplier decisions.
Support business continuity and technology transfer by identifying preferred and alternate materials or suppliers, evaluating comparability and process or product-quality impact, and recommending appropriate mitigation strategies.
Provide technical input for due diligence, quality agreements, supplier technical visits, audits, deviations, investigations, change controls, process validation, regulatory submissions, health-authority questions, and inspections.
Plan and execute laboratory or external testing, as needed, to characterize material variability, investigate manufacturing issues, and establish relationships between material attributes, process performance, and product quality.
Develop and improve standards, procedures, templates, databases, and knowledge-management tools that enable consistent material controls and reuse of data across programs and sites.
Communicate complex technical findings and recommendations to project teams and senior stakeholders, clearly documenting assumptions, risks, decisions, and follow-up actions.