Role at a glance
- Job function
-
Engineering & R&D Materials Science & Metallurgical Engineering
- Salary
- Not Disclosed
- Location
- Foster City, California, United States
- Work arrangement
- On-site
- Employment
- Full-time
- Experience
- PhD in materials science, chemical engineering, chemistry, biochemistry, pharmaceutical sciences, biotechnology, or a related scientific...
- Education
- PhD in materials science, chemical engineering, chemistry, biochemistry, pharmaceutical sciences, biotechnology, or a related scientific...
Spotted an issue?
We’ll check it against the original posting.
Role Summary
The Scientist, Materials Science provides scientific and technical leadership for product-contact materials used in biologics development and manufacturing. The role develops and manages material qualification and control approaches and communicates evidence-based recommendations to project teams and senior stakeholders.
What You'll Do
- Lead material risk assessments and define material requirements, critical attributes, specifications, testing strategies, and mitigations.
- Drive material qualification from identifying a need through supplier selection, technical qualification, GMP implementation, and...
- Assess extractables and leachables, chemical compatibility, supplier documentation, and supplier-initiated changes; prepare technical...
- Support business continuity and technology transfer by evaluating alternate materials and suppliers, comparability, and process or...
- Plan and execute material characterization testing to investigate manufacturing issues and assess relationships between material...
- Develop standards, procedures, templates, databases, and knowledge-management tools for material controls.
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
Requires a qualifying scientific degree and relevant industry experience, including experience supporting biologic drug substance or drug product development, technology transfer, or manufacturing in a regulated biopharmaceutical environment. Requires expertise in at least one listed material category, working knowledge of material characterization and GMP expectations, and ability to lead complex technical work and make clear recommendations.
Required
- Experience supporting development, technology transfer, or manufacturing of biologic drug substance or drug product in a regulated...
- Demonstrated expertise with one or more material categories, such as process chemicals, media, excipients, chromatography resins,...
- Working knowledge of material characterization, specifications, supplier technical documentation, risk assessment, change management,...
- Demonstrated ability to lead complex technical work independently, manage multiple priorities, and deliver clear recommendations in a...
Preferred
- Advanced knowledge of single-use technologies, polymer science, extractables and leachables, chemical compatibility, filtration, resin...
- Knowledge of applicable pharmacopeial standards and global regulatory expectations for raw materials, excipients, single-use systems,...
- Experience developing science- and risk-based material control strategies, conducting supplier technical due diligence, and supporting...
- 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...
- Excellent communication, collaboration, and influencing skills across technical, quality, regulatory, manufacturing, and supply-chain...
- Demonstrated scientific curiosity, sound judgment, accountability, and commitment to continuous improvement and knowledge sharing.
Original job description
Content provided by the employer
Original job description
Content provided by the employer
At 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, determination 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 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.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* 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 [email protected] for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Gilead 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.
About the company
Gilead Sciences
Large Enterprise
Gilead Sciences is a biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines to treat life-threatening diseases, particularly in the fields of antiviral therapies, oncology, and inflammatory conditions. Founded in 1987 and headquartered in Foster City, California, Gilead has made significant advancements in the treatment of HIV, hepatitis B and C, and certain cancers. With a commitment to improving patient outcomes through science and research, Gilead continues to expand its portfolio of medicines that address unmet medical needs worldwide.