Principal Scientist — Reference Standard & Critical Reagents Lead

Job Description

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.

At Gilead's 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, Reference Standard & Critical Reagents Lead at Gilead you will be vital to the success of Clinical Biologics QC.

Providing strategic leadership and overseeing daily operations for reference standards and critical reagents.

• Own and manage the full lifecycle of reference standards and critical reagents (primary, secondary/working, interim, compendial, in-house, impurity), from receipt and qualification through use, requalification, and retirement.
• Ensure uninterrupted supply and inventory control of qualified reference standards to support GMP testing and product release.
• Coordinate qualification and bridging studies for working standards against primary standards, ensuring complete documentation and traceability.
• Define and ensure appropriate storage, handling, monitoring, and shipping conditions for reference standards, including management of excursions.
• Author, review, and maintain GMP documentation such as SOPs, qualification/requalification protocols and reports, CoAs/CoCs, and standard preparation and issuance records.
• Maintain accurate records in electronic systems (e.g., LIMS, ELN, EDMS) in compliance with ALCOA+ data integrity principles.
• Provide technical input to assay qualification/validation and review test methods and release documentation involving reference standards.
• Review and manage deviations, OOS/OOT results, risk assessments, and CAPAs.
• Ensure inspection readiness and support internal and external audits.
• Author, review, and maintain GMP documentation, including protocols, reports, SOPs, deviations, change controls, CAPAs, and study closeout documentation.
• Collaborate cross‑functionally with QC, CMC, Regulatory Affairs, Manufacturing, and Supply Chain to support stability commitments, filings, and health authority responses.

• Experience with Biologics 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.
• Proven ability to work with senior management to…