Principal Scientist, External Quality Testing

Gilead Sciences • Foster City, CA

3d

About The Position

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 ...

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.
• 10+ years’ experience with a BS, OR 8+ years’ experience with a MS OR 5+ years’ experience with a PhD Chemistry, Biochemistry or related field
• 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.

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.

Benefits

• This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
• Benefits include company-sponsored medical, dental, vision, and life insurance plans.
• For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree