Research Scientist - Biologics Analytical Operations
Research Scientist - 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 need 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.
- Teamwork, critical thinking, and the ability to convey complex and nuanced concepts to interdisciplinary teams are required.
- Contributes to analytical method development and qualification to support protein characterization activities.
- Operate, maintain, and troubleshoot Waters and Bruker QTOFs and Thermo Orbitraps.
- 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, Mascot, and Skyline) and data analysis/visualization tools (Python, R, JMP, and Spotfire).
- Participates in technology transfer of assays from analytical development to QC and external CRO/CMOs.
- Works as part of a team to characterize molecules, degradation pathways and define critical quality attributes in a phase-appropriate context.
- Participates in process comparability studies and coordinates analysis of in-process and product-related impurities as needed.
- The candidate will be expected to work in a matrixed environment and be an effective communicator of ideas, assay results and issues.
- Maintains familiarity with scientific literature and applies appropriately to projects.
- Represents the company at national/international conferences.
Essential Duties and Job Functions:
- Responsible for conducting scientific research for the development of drug candidates or the research support of marketed drugs.
- Applies scientific principles and techniques to products and problems.
- Works in collaboration with more junior and more senior scientists and directors to advance the development of state-of-the-art techniques to characterize substances, assays, and tools.
- Works on moderately complex problems where analysis of situations or data requires evaluation of intangible variables, requiring regular use of intelligence, logic, ingenuity, and creativity.
- Advises Research Associates or members of project teams in planning and execution of laboratory experimentation, considering economic, regulatory and safety factors.
- Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work.
- Maintains full working knowledge of state-of-the art principles and theories, applying such knowledge to the direction that supports Company interests.
- Demonstrates technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design and strategy.
- 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.
Knowledge, Experience and Skills:
- PhD in Chemistry or a related discipline with limited industry experience.
- BS or MS degree with extensive industry experience.
- Requires relevant experience that demonstrates an expertise and sustained excellence in performance and accomplishments that align to company goals.
- Excellent communication skills (both verbal and technical) and interpersonal skills are required. Must be able to participate in highly effective teams.
- Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
- Demonstrates ability to recognize anomalous and inconsistent results and interpret outcomes.
- Maintains in-depth knowledge of state-of-the art principles and theories, applying such knowledge to the direction that supports Company interests. Demonstrates technical proficiency, scientific rigor, collaboration with others and independent thought in suggesting experimental design and strategy.
- 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.
- Strong knowledge in mass spectrometry, experimental design, and assay development.
- Familiarity in chromatography and mass spectrometry for protein or carbohydrate characterization is expected.
- Performs a variety of experiments that support protein analytical characterization activities in various disciplines. Includes operating equipment, selecting appropriate methods and techniques, analyzing data and preparing related reports/presentations.