Gilead Sciences-posted 2 days ago
Full-time • Mid Level
Foster City, CA
5,001-10,000 employees

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.  As a Senior Scientist, Analytical Operations , at Gilead you will ... Work closely with high-throughput team lead and Foster City-based staff to ensure maintenance and management remain aligned across different testing sites. Conduct High-Throughput Testing & Technology Implementation Implement rapid testing capabilities at the Foster City site, including instrument setup/qualification, sample submission process design, and personnel training. Perform high-throughput analytical testing to support process development across diverse techniques: Liquid Chromatography (LC), Capillary Electrophoresis (CE), Compendial and ELISA-based assays. Drive adoption of novel characterization technologies and automation and support the team on business processes improvement to enhance throughput, data quality, and decision-making speed. The Analytical Operations department is seeking a highly motivated Senior Scientist to join as an integral member of our rapid testing team. The ideal candidate must possess strong leadership skills to drive the implementation, testing, and iterative improvements for rapid testing, which spans physicochemical, compendial and plate-based assays. A strong understanding of regulatory expectations, risk assessment, and the role of rapid testing in biopharmaceutical development is essential. The candidate should be adept at troubleshooting complex assays, interpreting data, and driving innovation in rapid testing to support process development and product characterization. Scientific Expertise & Innovation Demonstrate comprehensive knowledge in key analytical CMC areas: CQAs, method bridging, reference standards, comparability, and specifications. Contribute to method development and qualification for LC, CE, and MS-based assays supporting product and process characterization. Represent Analytical Development in cross-functional project teams internally and present at national/international conferences externally. Provide guidance to junior team members on experimental planning and execution, considering economic, regulatory, and safety factors. Operational Excellence Ensure high-quality, traceable results (ALCOA principles) and implement lean processes for efficient data packages. Participate in technology transfer of assays to QC and external CRO/CMOs. Maintain familiarity with state-of-the-art scientific principles and apply them to projects.

  • Work closely with high-throughput team lead and Foster City-based staff to ensure maintenance and management remain aligned across different testing sites.
  • Implement rapid testing capabilities at the Foster City site, including instrument setup/qualification, sample submission process design, and personnel training.
  • Perform high-throughput analytical testing to support process development across diverse techniques: Liquid Chromatography (LC), Capillary Electrophoresis (CE), Compendial and ELISA-based assays.
  • Drive adoption of novel characterization technologies and automation and support the team on business processes improvement to enhance throughput, data quality, and decision-making speed.
  • Demonstrate comprehensive knowledge in key analytical CMC areas: CQAs, method bridging, reference standards, comparability, and specifications.
  • Contribute to method development and qualification for LC, CE, and MS-based assays supporting product and process characterization.
  • Represent Analytical Development in cross-functional project teams internally and present at national/international conferences externally.
  • Provide guidance to junior team members on experimental planning and execution, considering economic, regulatory, and safety factors.
  • Ensure high-quality, traceable results (ALCOA principles) and implement lean processes for efficient data packages.
  • Participate in technology transfer of assays to QC and external CRO/CMOs.
  • Maintain familiarity with state-of-the-art scientific principles and apply them to projects.
  • Ph.D. in Biochemistry or related discipline with 2+ years of industry experience OR MS degree in Biochemistry or related discipline with 6+ years of industry experience OR B.S. degree in Biochemistry or related discipline with 8+ years of industry experience
  • Significant experience with rapid testing instrumentation, automation, and data processing.
  • Proficiency in LC, CE, MS, and advanced characterization techniques.
  • Familiarity with intact mass analysis, MS/MS for protein/carbohydrate characterization, kinetic analyses, and ultra-performance chromatography.
  • Working knowledge of lab automation, computer validation, data governance, and data protection.
  • Strong understanding of FDA and ICH guidelines for biologics registration and compliance.
  • Demonstrated ability to mentor junior scientists and manage resources effectively.
  • Strong business acumen with ability to balance budget, timelines, and program milestones.
  • Commitment to inclusion, talent development, and team empowerment.
  • Excellent communication, critical thinking, and organizational skills.
  • Ability to work independently and thrive in a matrixed environment.
  • This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
  • Benefits include company-sponsored medical, dental, vision, and life insurance plans.
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