Role Summary
Sr Scientist, Analytical Ops at Gilead - responsible for analytical characterization and method development supporting biologics programs in late-stage development and marketed products. Focus areas include mass spectrometry, protein characterization, and collaboration across cross-functional teams to advance analytical capabilities and ensure quality attributes.
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
- BS degree with at least 8 years of industry experience OR MS degree with at least 6 years of industry experience.
- Strong knowledge of mass spectrometry, experimental design, and assay development.
- Demonstrated ability to lead in a cross-functional environment and mentor junior team members.
- Ability to work independently with minimal supervision.
- Excellent verbal, technical writing, and interpersonal communication skills.
- Proficient in Microsoft Office applications.
- PhD in Chemistry or related discipline with at least 2 years of industry experience (preferred).
Skills
- Peptide mapping by LC-MS/MS
- Intact mass analysis
- MS/MS for protein and carbohydrate structural elucidation/quantification
- Kinetic analyses
- Ultra-performance chromatography
- Proteolytic/chemical processing
- ICH guidelines and GMP
- Mass spectrometry analysis software (Protein Metrics, Thermo BioPharma Finder, Skyline)
- Data analysis and visualization tools (Python, R, JMP, Spotfire)
- Strong organizational and planning skills
- Ability to work effectively in a matrixed environment and communicate assay results and issues clearly
Education
- BS/MS with relevant experience; PhD preferred (Chemistry or related discipline)
Additional Requirements
- At a future date this position will relocate to the corporate HQ in Foster City, CA.