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Sr. Scientist

United States - California - OceansideProcess/Product Development & OperationsRegular

Description de l'emploi

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.

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

Essential Duties and Job Functions:

  • Works as part of a team to support late-stage assay development by performing mass spectrometry to characterize molecules, degradation pathways, and define critical quality attributes in a phase-appropriate context.

  • Contributes to analytical method development and qualification to support protein characterization activities.

  • Develops new assays to gain competitive advantages over standard industry practices.

  • Supports comparability and stability studies by mass spectrometry.

  • Operates, maintains, and troubleshoots Waters, Sciex and Bruker QTOFs and Thermo Orbitrap mass spectrometers.

  • Works on complex problems where analysis of situations or data requires evaluation of intangible variables requiring regular use of intelligence, logic, ingenuity, and creativity.

  • Works in collaboration with junior and senior team members to advance the development of state-of-the-art techniques to characterize substances, assays, and tools.

  • Represents the Structure Characterization group in cross-functional project teams.

  • Participates in technology transfer of assays from analytical development to QC and external CRO/CMOs.

  • Participates in process comparability studies and coordinates analysis of in-process and product-related impurities as needed.

  • Responsible for conducting scientific research for the development of drug candidates or research support of marketed drugs.

  • Advises project teams on the planning and execution of laboratory experiments, considering economic, regulatory and safety factors.

  • Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work.

  • Maintains familiarity of state-of-the art scientific principles and literature and applies such knowledge appropriately to projects and in support of the Company’s interests.

  • Represents the company at national/internationalconferences.

Knowledge, Experience and Skills:

  • PhD in Chemistry or a related discipline with at least 3 years industry experience, OR BS or MS degree with extensive industry experience.

  • Strong knowledge in mass spectrometry, experimental design, and assay development.

  • Dermonstrated ability to lead in a cross-functional environment and mentor junior team members.

  • Ability to work independly with little supervision.

  • Familiarity with several of the following is highly desired: 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. Knowledge of ICH guidelines and GMP is a plus.

  • Expertise in mass spectrometry analysis software (Protein Metrics, Thermo BioPharma Finder and Skyline) and data analysis/visualizationtools (Python, R, JMP, and Spotfire).

  • Excellent communication skills (both verbal and technical) and interpersonal skills are required. Must be able to participate in highly effective teams.

  • Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.

  • The candidate will be expected to work in a matrixed environment and be an effective communicator of ideas, assay results and issues.