Scientist, Materials Science
Gilead SciencesAt 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, determina
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tion 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
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.
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