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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 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.
Basic Qualifications:
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. Preferred
Qualifications:
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. The salary range for this position is: $146,540.00 - $189,640.00. 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: * 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 ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTGilead 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.
Summary
Location: United States - California - Foster City
Type: Full time
