Senior Scientist, Analytical Operations

职位描述

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.

Qualifications

***At a future date, this position will relocate from Oceanside CA to the Gilead corporate HQ in Foster City, CA or will be hired directly to Foster City CA.**

Education & Experience

• 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

Technical Expertise & Regulatory Knowledge

• 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.

Communication & Collaboration

• 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.

People Leader Accountabilities:

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.