Senior Associate Scientist, Analytical Operations
美国 - 加利福尼亚州 - 福斯特市产品开发和运营正式员工职位描述
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 Associate Scientist, Analytical Operations, at Gilead you will ...
Perform Analytical Method Development & Testing
Perform Liquid Chromatography (LC), Capillary Electrophoresis (CE), and ELISA-based assays to evaluate the impact of process parameters on product quality.
Support method development, optimization, and validation for late-stage biotherapeutics in compliance with regulatory guidelines.
Participate in process development, characterization, and comparability studies and analyze in-process and product-related impurities.
The successful candidate will possess an understanding of analytical tools for therapeutic biologics process and product characterization as well as design and execute experiments to automate analytical tools to boost workflow efficiency. 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, high performance or ultra-performance liquid chromatography, electrophoretic separations, ELISA-based methods, automation (such as Hamilton and Tecan), and bioinformatics.
Automation & Workflow Optimization
Independently design and execute automation strategies to improve end-to-end testing efficiency, including data management tools.
Operate, maintain, and troubleshoot automated liquid handling systems (Hamilton and Tecan) and other laboratory automation platforms.
Lead technology development projects to implement innovative solutions and gain competitive advantages over standard industry practices.
Collaboration & Scientific Leadership
Work closely with cross-functional teams to advance analytical technologies and automation workflows.
Provide input on experimental planning and execution, considering economic, regulatory, and safety factors.
Present results, interpret data, and draw scientifically sound conclusions.
Documentation & Compliance
Author and revise analytical methods, protocols, and reports in accordance with GMP/GxP standards.
Review testing data for accuracy and compliance with established protocols and specifications.
Continuous Learning & Representation
Stay current with scientific literature and novel technologies and apply knowledge to ongoing projects.
Represent Gilead at national and international conferences, sharing insights and advancements in biologics analytical development.
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
Bachelor’s degree in a relevant scientific discipline (e.g., bioengineering, chemical engineering, biochemical engineering) with 5+ years of experience OR
Master’s degree with 3+ years of experience in biologics analytical development.
Technical Skills
Hands-on experience with LC, CE, ELISA-based methods, and laboratory automation workflows.
Proficiency in operating and troubleshooting Hamilton and Tecan systems.
Knowledge of ICH guidelines, GMP/GxP practices is highly preferred.
Core Competencies
Strong problem-solving skills and ability to proactively identify and implement solutions.
Excellent organizational and communication skills.
Ability to work independently and collaboratively in a multidisciplinary environment.