Scientist, Analytical Ops

Biologics Analytical Operations

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of strong late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

The successful candidate will possess a detailed understanding of proteins and carbohydrates. The candidate must be highly motivated to contribute to the research and development of biologics targeting unmet medical needs through biochemical characterization and novel method development supporting clinical and commercial programs. Experience in several of the following fields is strongly desired: analytical chemistry, biochemistry, biological mass spectrometry, high performance or ultra-performance liquid chromatography, electrophoretic separations, enzymology, statistics, chemical and biophysical structural elucidation, and bioinformatics.

Key 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 activities.
• Support comparability and stability studies using mass spectrometry.
• Operate, maintain, and troubleshoot Waters, Sciex, Agilent, Bruker QTOFs, and Thermo Orbitrap mass spectrometers.
• Collaborate with team members to develop advanced techniques for substance, assay, and tool characterization.
• Represent the Structure Characterization group in cross-functional project teams.
• Participate in technology transfer of assays from analytical development 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 experimental results, interpret data, and draw conclusions.
• Stay current with scientific literature and apply relevant knowledge to projects.
• Represent the company at national and international conferences.

Basic Qualifications

• BS degree with at least six (6) years of industry experience OR MS degree with at least four (4) years of industry experience.
• Strong knowledge of mass spectrometry, experimental design, and assay development.
• Excellent verbal, technical writing, and interpersonal communication skills.
• Ability to work independently and collaboratively in a matrixed environment.
• Strong organizational and planning skills.
• Proficient in Microsoft Office applications.

Preferred Qualifications

• PhD in Chemistry or a related discipline with limited industry experience
• Familiarity with techniques such as:
  • 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
• Knowledge of ICH guidelines and GMP.
• Expertise in mass spectrometry analysis software (Protein Metrics, Thermo BioPharma Finder, Skyline).
• Experience with data analysis and visualization tools (Python, R, JMP, Spotfire).
• Demonstrated ability to mentor junior team members and lead in cross-functional environments.