Scientist, Materials Science
$146.54k - $189.64kGilead
At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.
Every member of Gileads 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 were 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 DescriptionThe 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:
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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 disabilitygenetic 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 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 for assistance.
For more information about equal employment opportunity protections please view the Know Your Rights poster.
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.
Required Experience:
IC
$146.54k - $189.64k
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