Senior Scientist, Quality Control

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 Senior Scientist, Quality Control at Gilead, you will have the following responsibilities-

Key Responsibilities

• Serve as the primary QC representative for assigned products, providing QC leadership and analytical subject matter expertise across product and analytical sub-teams, PDM teams, PQTs, and other cross-functional forums.
• Provide end-to-end QC oversight for assigned products, coordinating QC activities and deliverables across manufacturing, testing, analytical methods, stability, regulatory submissions, and commercial lifecycle activities.
• Lead oversight of contract testing laboratory activities, including testing execution, GMP sample shipment coordination, laboratory investigations and deviations, change controls, and resolution of testing-related issues.
• Provide analytical and QC input to manufacturing investigations and deviations, partnering with Manufacturing, Quality, technical functions, and testing laboratories to assess product and method impact and support appropriate resolution.
• Lead lifecycle management of analytical methods and associated QC testing strategies, including method implementation, transfer, validation/verification, changes, performance monitoring, and continued suitability for commercial testing.
• Provide QC input and review for regulatory submissions and post-approval changes, including BLA/NDA content, responses to regulatory questions, and assessment of QC impacts associated with filing commitments.
• Coordinate the review and approval of commercial specifications and associated testing requirements, ensuring alignment with regulatory filings, analytical capabilities, product knowledge, and applicable quality requirements.
• Provide QC oversight and coordination for product changes, assessing impacts to analytical methods, specifications, testing laboratories, sample management, stability, and other QC deliverables and ensuring appropriate implementation.
• Partner cross functionally with Quality Control, Quality Assurance, Manufacturing, Regulatory, Supply Chain and other technical functions to ensure QC deliverables, risks, dependencies, and issues are appropriately identified, communicated, and managed throughout the product lifecycle.
• Serve as a QC subject matter expert and technical escalation point, providing recommendations, driving resolution of analytical and testing issues, and communicating QC risks, decisions, and priorities to cross-functional stakeholders.
• Author, review, and maintain GMP documentation, including protocols, reports, SOPs, deviations, change controls, CAPAs, and study closeout documentation.

Experience

You have:

• Experience with Commercial Quality Control with knowledge of industry best practices and trends for reference standards, stability and/or raw materials.
• In-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally.
• Must be able to develop and improve complex concepts, techniques, standards and new applications based on quality principles and theories.
• Must be able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovation.
• Must be able to exercise judgment and independently determine and take appropriate action where precedent may not exist.

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