Principal Scientist, External Quality Testing

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
 

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 Principal Scientist, at Gilead you will ... 

Key Responsibilities:

• Provide strategic leadership and oversight for External QC operations supporting Gilead’s commercial biologics portfolio, setting long‑term direction for QC excellence.

• Lead the strategy and execution of release testing for commercial biologics drug substances and drug products, ensuring delivery of compliant, reliable analytical data.

• Develop and drive commercial specification strategies and oversee the life‑cycle management of reference standards and critical reagent programs.

• Lead analytical method validation and transfer strategies, ensuring methods remain robust, current, and aligned with global regulatory expectations.

• Direct the compendial review program, assessing emerging pharmacopeial changes and defining strategic responses to maintain compliance.

• Guide the monitoring of QC test method execution across the biologics network and drive improvements to ensure consistency, harmonization, and operational efficiency.

• Ensure all QC activities align with global cGMP and Gilead’s Quality Management System, while shaping the future state of QC capabilities and quality systems.

Requirements:

• Broad experience across QC sub‑functions with deep knowledge of current and emerging industry best practices and trends.

• In‑depth understanding and application of cGMP principles, standards, and global regulatory expectations.

• Demonstrated ability to develop and improve complex quality concepts, techniques, standards, and novel applications.

• Proven track record in solving complex problems using creativity, innovation, and strategic thinking.

• Ability to independently exercise judgment, make decisions without precedent, and set strategic direction in ambiguous situations.

• Experience partnering with senior leadership to develop and implement company‑wide, long‑term solutions.

• Demonstrated ability to define a vision for QC functions and shape organizational capabilities to fulfill that vision.

• Strong influencing and cross‑functional leadership skills with the ability to drive outcomes across multiple teams.

• Strong organizational planning, communication, and collaborative interpersonal skills.

• Critical and creative thinker able to work independently and identify appropriate resources to resolve challenges.

Qualifications:

• 10+ years’ experience with a BS, OR

• 8+ years’ experience with a MS OR

• 5+ years’ experience with a PhD