Senior Scientist, External Quality Testing

Gilead Sciences • Foster City, CA

2d

About The Position

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 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 fulfill their aspirations. Join Gilead and help create possible, together. 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.

Requirements

• Broad experience across QC sub‑functions with strong knowledge of industry practices and trends.
• In‑depth understanding and application of cGMP principles and standards in the US and internationally.
• Demonstrated knowledge and experience in biologics quality control, with the ability to stay ahead of evolving industry expectations.
• Ability to develop and improve complex QC concepts, techniques, and standards based on quality principles.
• Capable of generating solutions to complex operational problems requiring creativity and innovation.
• Exercises strong judgment and can act independently when precedent does not exist.
• Demonstrated ability to motivate, engage, and influence colleagues across functions to drive aligned QC operations
• Strong organizational and planning skills.
• Excellent written and verbal communication and collaborative interpersonal skills.
• 8+ years’ related experience with a BS, OR 6+ years’ experience with a MS OR 2+ 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

• Lead daily External QC operations, including coordination of testing logistics, reference standard inventories, and data entry from CTLs/CMOs into Gilead’s LIMS.
• Oversee execution of commercial specification activities, reference standards and critical reagents programs, analytical method validations and transfers, and compendial review work supporting lifecycle management of commercial biologics.
• Manage release testing activities for commercial biologics drug substances and drug products, ensuring timely and compliant execution across external sites.
• Refine and implement QC procedures across the biologics manufacturing network to maintain global cGMP and Gilead QMS compliance.
• Collaborate closely with cross‑functional PDM project teams to support method execution, coordinate QC deliverables, and ensure consistent analytical operations.
• Monitor QC method execution and identify opportunities to enhance efficiency, reliability, and alignment across testing sites.
• Contribute to continuous improvement efforts that strengthen operational performance and ensure cohesive, compliant, and efficient analytical workflows.

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.

What This Job Offers

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