At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
The Scientist, Analytical Ops provides analytical and scientific leadership to support the development, characterization, and advancement of drug candidates. Working across analytical disciplines and functions, this role plans and executes laboratory activities, develops fit-for-purpose analytical methods, and interprets scientific data to address complex development challenges. The Scientist applies strong laboratory expertise and scientific judgment to strengthen product understanding, inform impurity control strategies, and support timely project decisions. This work contributes to the analytical development activities needed to advance clinical programs and key development deliverables.
This position is based in Foster City, CA and is fully onsite.
As a Scientist, Analytical Ops at Gilead, you will...
Key Responsibilities:
Provide technical leadership in the development and optimization of analytical methods for complex or challenging assignments.
Define analytical strategies, approaches, and techniques that address technical needs and advance project objectives.
Design, plan, and execute laboratory experiments to resolve complex analytical and development challenges.
Maintain a strong hands-on laboratory presence and apply scientific judgment to troubleshoot experiments, interpret data, and resolve technical issues.
Anticipate analytical needs across the drug development process and proactively address evolving project requirements.
Plan, prioritize, and execute analytical activities for raw materials, intermediates, drug substances, and drug products in alignment with project objectives and development timelines.
Design and perform physicochemical analyses, including liquid chromatography, gas chromatography, and Karl Fischer analysis.
Conduct fit-for-purpose development studies, including stress and degradation studies and accelerated stability approaches, to strengthen product understanding and inform development strategies.
Develop and apply sensitive analytical methods to assess process-related impurities, mutagenic and potentially mutagenic impurities, and nitrosamines, where applicable.
Contribute to scientifically sound impurity control strategies based on analytical findings and development needs.
Provide analytical expertise to support the development and characterization of formulations, product intermediates, and dosage forms, including solid oral, parenteral, and combination products.
Apply Quality by Design principles, including Design of Experiments and Method Operable Design Region approaches, to develop robust analytical methods and support method understanding consistent with ICH Q14 principles.
Maintain current knowledge of scientific literature, emerging analytical technologies, and relevant regulatory expectations and apply this knowledge to development…