Scientist, Analytical Ops

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.
• Conduct analytical testing and characterization using advanced instrumentation including GC-MS, LC-UV/MS, LC-MS/MS, HRMS, and ICP-MS.
• Identify and characterize unknown compounds using spectral libraries and structure elucidation tools.
• Develop, optimize, and verify analytical methods for E&L testing across complex pharmaceutical matrices.
• Utilize sample preparation techniques such as Solid-phase extraction (SPE), Liquid-liquid extraction (LLE), and protein precipitation.
• Collaborate with toxicology, device/packaging, and formulation development teams to support product lifecycle activities.
• Ensure compliance with regulatory guidelines and standards including USP, FDA, EMA, ICH, and PQRI.

Requirements

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

Preferred Qualifications

• PhD in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
• Experience with regulatory submissions and E&L strategy development.
• Strong understanding of structural characterization and compound identification techniques.
• Track record of scientific publications and conference presentations.
• Excellent analytical thinking, problem-solving, and troubleshooting skills.

About the Company

Gilead is a research-based biopharmaceutical company that has tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer for more than 35 years. We work relentlessly to develop therapies that help improve lives and ensure access to these therapies across the globe.