Sr Scientist, Analytical Ops

Role Summary

Sr Scientist, Analytical Ops at Gilead Sciences, Inc. The role focuses on analytical characterization and method development for biologics, supporting clinical and commercial programs, with emphasis on mass spectrometry, chromatography, and related analytical techniques. The candidate contributes to late-stage assay development, technology advancement, and cross-functional collaboration to advance drug candidates and marketed products.

Responsibilities

• Support late-stage assay development by performing mass spectrometry to characterize molecules, degradation pathways, and define critical quality attributes in a phase-appropriate context.
• Contribute to analytical method development and qualification for protein characterization.
• Develop innovative assays to gain competitive advantages over standard industry practices.
• Support comparability and stability studies using mass spectrometry.
• Operate, maintain, and troubleshoot Waters, Sciex, Bruker QTOFs, and Thermo Orbitrap mass spectrometers.
• Solve complex problems requiring evaluation of intangible variables using logic, ingenuity, and creativity.
• Collaborate with junior and senior team members to advance state-of-the-art characterization techniques.
• Represent the Structure Characterization group in cross-functional project teams.
• Participate in technology transfer of assays to QC and external CRO/CMOs.
• Coordinate analysis of in-process and product-related impurities for process comparability studies.
• Conduct scientific research to support drug candidate development and marketed drug research.
• Advise project teams on experiment planning and execution, considering economic, regulatory, and safety factors.
• Present results, interpret data, and draw conclusions from experimental findings.
• Stay current with scientific literature and apply relevant knowledge to projects.
• Represent the company at national and international conferences.

Qualifications

• Required: BS degree with at least 8 years of industry experience OR MS degree with at least 6 years of industry experience.
• Required: Strong knowledge of mass spectrometry, experimental design, and assay development.
• Required: Demonstrated ability to lead in a cross-functional environment and mentor junior team members.
• Required: Ability to work independently with minimal supervision.
• Required: Excellent verbal, technical writing, and interpersonal communication skills.
• Required: Proficient in Microsoft Office applications.
• Preferred: PhD in Chemistry or related discipline with at least 2 years of industry experience.
• Preferred: Familiarity with peptide mapping by LC-MS/MS, intact mass analysis, MS/MS for protein and carbohydrate structural elucidation/quantification, kinetic analyses, ultra-performance chromatography, and proteolytic/chemical processing.
• Preferred: Knowledge of ICH guidelines and GMP.
• Preferred: Expertise in mass spectrometry analysis software (Protein Metrics, Thermo BioPharma Finder, Skyline).
• Preferred: Experience with data analysis and visualization tools (Python, R, JMP, Spotfire).
• Preferred: Strong organizational and planning skills.
• Preferred: Ability to work effectively in a matrixed environment and communicate assay results and issues clearly.

Education

• PhD in Chemistry or related discipline (preferred).
• MS or BS with relevant industry experience acceptable per qualifications.

Additional Requirements

• At a future date this position may relocate to the corporate HQ in Foster City, CA.