Role Summary
As a Senior Associate Scientist, Analytical Operations, at Gilead you will contribute to analytical method development and testing, automate analytical workflows, and collaborate with cross-functional teams to advance analytical technologies in support of clinical and commercial programs.
Responsibilities
- 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.
- 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.
- 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.
- 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.
- 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, relocation from Oceanside CA to Foster City, CA or direct hire to Foster City CA.
Education
- Bachelorโs degree in a relevant scientific discipline (e.g., bioengineering, chemical engineering, biochemical engineering) with 5+ years of experience OR
- Masterโs 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.