Scientist, Analytical Ops

Key Responsibilities

• 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.
• Conduct and/or oversee analytical testing using advanced instrumentation such as 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.
• 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), and protein precipitation.
• Apply semi‑quantitative approaches using surrogate standards and justify analytical uncertainty where authentic standards are unavailable.
• 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.
• 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.

• BSc with at least 8 years of relevant experience.
• MSc with at least 6 years of relevant experience.

• PhD in Analytical Chemistry, Pharmaceutical Sciences, or a related field with experience in trace‑level impurity detection and identification.
• 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 ability to influence cross‑functional stakeholders.
• Ability to thrive in a collaborative, fast‑paced environment.

Salary range: $ – $. Additional compensation may include discretionary annual bonus, discretionary stock‑based long‑term incentives, paid time off, and a benefits package featuring company‑sponsored medical, dental, vision, and life insurance 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 Appli for assistance. For more information about equal employment opportunity protections, please view the "Know Your Rights" poster.

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