Scientist, Analytical Ops
Gilead Sciences
2 months ago
Remote friendly (San Francisco Bay Area)
United States
Operations
Key Responsibilities:
- Design and execute extractables and leachables (E&L) studies for 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 GC-MS (including headspace and direct inject), LC-UV/MS, LC-MS/MS, HRMS, and 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 screening strategies for extractables and leachables assessments.
- Use sample preparation methods: SPE, LLE, protein precipitation.
- Apply semi-quantitative approaches with surrogate standards; justify analytical uncertainty when 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.
- Present findings/recommendations to inform technical strategy and decisions.
Documentation & Compliance:
- Author/review/approve technical reports ensuring scientific accuracy, data integrity, and traceability.
- Ensure compliance with USP, FDA, EMA, ICH, and PQRI.
Basic Qualifications:
- BSc + at least 8 years relevant experience OR MSc + at least 6 years relevant experience.
Preferred Qualifications:
- PhD in Analytical Chemistry/Pharmaceutical Sciences (0+ years); trace-level impurity detection/identification.
- Experience with GC-MS, LC-UV/MS, HRMS, ICP-MS.
- Sample prep experience (SPE, LLE, protein precipitation).
- Structural characterization/compound identification.
- Regulatory submissions and E&L strategy development.
- Publications/conference presentations.
- Strong analytical thinking, troubleshooting, and communication.
Application Instructions:
- For current Gilead employees/contractors: apply via the Internal Career Opportunities portal in Workday.
- Design and execute extractables and leachables (E&L) studies for 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 GC-MS (including headspace and direct inject), LC-UV/MS, LC-MS/MS, HRMS, and 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 screening strategies for extractables and leachables assessments.
- Use sample preparation methods: SPE, LLE, protein precipitation.
- Apply semi-quantitative approaches with surrogate standards; justify analytical uncertainty when 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.
- Present findings/recommendations to inform technical strategy and decisions.
Documentation & Compliance:
- Author/review/approve technical reports ensuring scientific accuracy, data integrity, and traceability.
- Ensure compliance with USP, FDA, EMA, ICH, and PQRI.
Basic Qualifications:
- BSc + at least 8 years relevant experience OR MSc + at least 6 years relevant experience.
Preferred Qualifications:
- PhD in Analytical Chemistry/Pharmaceutical Sciences (0+ years); trace-level impurity detection/identification.
- Experience with GC-MS, LC-UV/MS, HRMS, ICP-MS.
- Sample prep experience (SPE, LLE, protein precipitation).
- Structural characterization/compound identification.
- Regulatory submissions and E&L strategy development.
- Publications/conference presentations.
- Strong analytical thinking, troubleshooting, and communication.
Application Instructions:
- For current Gilead employees/contractors: apply via the Internal Career Opportunities portal in Workday.