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United States - California - Foster City, United States of America
Onsite
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
Key Responsibilities:
Extractables & Leachables (E&L) Strategy & Execution
Design and execute extractables and leachables (E&L) studies to support injectable biological drug products, container closure systems, and medical devices.
Develop and author E&L protocols, reports, and risk assessments in alignment with regulatory expectations.
Evaluate leachable profiles across stability studies, identifying trends and potential risks.
Analytical Testing & Characterization
Conduct and/or oversee analytical testing using advanced instrumentation, including:
GC-MS, Headspace and Direct Inject
LC-UV/MS, LC-MS/MS
High-Resolution Mass Spectrometry (HRMS)
ICP-MS (elemental impurities)
Identify and characterize unknown compounds using spectral libraries and structure elucidation tools.
Perform trace-level quantification of leachables and extractables in complex matrices.
Support contract laboratory oversight, including study design review, execution monitoring, and data verification.
Method Development & Validation
Develop, optimize, and verify analytical methods for E&L testing across complex pharmaceutical matrices.
Implement screening strategies for extractables and leachables assessments.
Utilize appropriate sample preparation techniques, including:
Solid-phase extraction (SPE)
Liquid-liquid extraction (LLE)
Protein precipitation
Apply semi-quantitative approaches using surrogate standards and justify analytical uncertainty where authentic standards are unavailable.
Cross-Functional Collaboration
Collaborate with toxicology teams to assess patient risk and establish Analytical Evaluation Threshold (AET)
Partner with Device/Packaging, Process Development, and Formulation Development teams to support product lifecycle activities.
Present findings and recommendations using a data-driven approach to inform technical strategy and decision-making.
Documentation & Compliance
Author, review, and approve technical reports and documentation, ensuring scientific accuracy, data integrity, and traceability.
Ensure compliance with applicable regulatory guidelines and standards (USP, FDA, EMA, ICH, PQRI).
Stay current with emerging technologies and industry trends and apply advancements to improve analytical capabilities.
Basic Qualifications:
BSc with at least 8 years of relevant experience
OR
MSc with at least 6 years of relevant experience
Preferred Qualifications:
PhD in Analytical Chemistry, Pharmaceutical Sciences, or a related field with 0+ years of experience, Strong expertise in trace-level impurity detection and identification.
Demonstrated experience with analytical instrumentation (GC-MS, LC-UV/MS, HRMS, ICP-MS).
Proven experience with sample preparation techniques (SPE, LLE, protein precipitation).
Strong understanding of structural characterization and compound identification techniques.
Experience with regulatory submissions and E&L strategy development.
Track record of scientific publications and conference presentations.
Excellent analytical thinking, problem-solving, and troubleshooting skills.
Strong communication and presentation skills, with the ability to influence cross-functional stakeholders.
Ability to thrive in a collaborative, fast-paced environment.
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.
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 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.
Please apply via the Internal Career Opportunities portal in Workday.