Scientist, Analytical Ops
Gilead Sciences
June 26, 2026
On-site
San Francisco Bay Area
Operations
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 aligned 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: GC-MS, Headspace/Direct Inject, LC-UV/MS, LC-MS/MS, 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 (study design review, execution monitoring, data verification).
Method Development & Validation
- Develop, optimize, and verify analytical methods for E&L testing across complex pharmaceutical matrices.
- Implement extractables/leachables screening strategies.
- Use sample preparation techniques: SPE, LLE, protein precipitation.
- Apply semi-quantitative approaches with surrogate standards and justify analytical uncertainty.
Cross-Functional Collaboration
- Partner with toxicology teams to assess patient risk and establish Analytical Evaluation Threshold (AET).
- Collaborate with Device/Packaging, Process Development, and Formulation Development to support product lifecycle activities.
- Present data-driven findings and recommendations.
Documentation & Compliance
- Author/review/approve technical reports ensuring scientific accuracy, data integrity, and traceability.
- Ensure compliance with USP, FDA, EMA, ICH, PQRI.
Basic Qualifications
- BSc with at least 8 years relevant experience OR MSc with at least 6 years relevant experience.
Preferred Qualifications
- PhD in Analytical Chemistry/Pharmaceutical Sciences (0+ years) with expertise in trace-level impurity detection/identification.
- Experience with GC-MS, LC-UV/MS, HRMS, ICP-MS; SPE/LLE/protein precipitation; structural characterization; regulatory submissions/E&L strategy; publications/conference presentations; analytical problem-solving; strong communication.
Application Instructions
- Apply via the Internal Career Opportunities portal in Workday (for current employees/contractors).
- 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 aligned 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: GC-MS, Headspace/Direct Inject, LC-UV/MS, LC-MS/MS, 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 (study design review, execution monitoring, data verification).
Method Development & Validation
- Develop, optimize, and verify analytical methods for E&L testing across complex pharmaceutical matrices.
- Implement extractables/leachables screening strategies.
- Use sample preparation techniques: SPE, LLE, protein precipitation.
- Apply semi-quantitative approaches with surrogate standards and justify analytical uncertainty.
Cross-Functional Collaboration
- Partner with toxicology teams to assess patient risk and establish Analytical Evaluation Threshold (AET).
- Collaborate with Device/Packaging, Process Development, and Formulation Development to support product lifecycle activities.
- Present data-driven findings and recommendations.
Documentation & Compliance
- Author/review/approve technical reports ensuring scientific accuracy, data integrity, and traceability.
- Ensure compliance with USP, FDA, EMA, ICH, PQRI.
Basic Qualifications
- BSc with at least 8 years relevant experience OR MSc with at least 6 years relevant experience.
Preferred Qualifications
- PhD in Analytical Chemistry/Pharmaceutical Sciences (0+ years) with expertise in trace-level impurity detection/identification.
- Experience with GC-MS, LC-UV/MS, HRMS, ICP-MS; SPE/LLE/protein precipitation; structural characterization; regulatory submissions/E&L strategy; publications/conference presentations; analytical problem-solving; strong communication.
Application Instructions
- Apply via the Internal Career Opportunities portal in Workday (for current employees/contractors).