Senior Associate Scientist, External Quality Analytical Oversight

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 Senior Associate Scientist, you will contribute to QC procedures across Gilead’s commercial manufacturing network, ensuring global cGMP compliance. The Associate Scientist collaborates with cross-functional teams, fosters a culture of continuous improvement, and supports the QC team for timely project completion and regulatory compliance.

This is a site-based position (up to 5x a week) in Foster City, CA.

Key Responsibilities

The Senior Associate Scientist in External Quality Analytical Oversight role supports external commercial QC through hands-on execution of activities and processes related to data review, documentation, method lifecycle support, and continuous improvement. Working within established procedures and with guidance from senior colleagues, the role helps ensure accurate, timely, and compliant QC deliverables.

Focus Areas

• Perform review of external QC laboratory data for commercial release and stability testing, including contract testing laboratory (CTL) Certificates of Analysis (CoA), stability reports, and supporting documentation, in accordance with Gilead procedures for oversight of contract laboratory data.
• Perform data-based review of CTL raw data packages, including verification of method conditions, sample and standard preparation, reference standard use, system suitability, representative chromatograms, and calculation accuracy; support Level 3 on-site data reviews as assigned.
• Use lab information management system (LIMS) to verify accurate transcription of results against CTL documents and specifications, complete test- and sample-level review and authorization, review audit trails, and generate provisional CoAs, Stability Summary Reports, and Analytical Reports.
• Use electronic documentation management system to retrieve, review, and accept CTL CoAs, stability reports, raw data packages, specifications, and test methods; maintain document metadata and workflows and document data review findings and discrepancies.
• Partner with QC Leads, CTLs, and QA to resolve data discrepancies, request and track CTL corrections, and ensure data review is completed within required turnaround times.
• Identify, document, and escalate data review findings, including atypical results, trends, and data integrity or ALCOA++ concerns; support related laboratory investigations (OOS/OOT/OOE), deviations, and CAPAs.
• Compile and report QC data-related metrics, maintain review and batch release trackers, and communicate status, turnaround times, and outstanding issues.
• Coordinate SAP specification authoring and updates with designated authors and QC stakeholders, tracking completion and confirming alignment with approved specifications.
• Contribute to continuous improvement of data review processes and electronic system workflows, including authoring or revising SOPs, work instructions, and job aids and supporting system changes and user testing.

Experience:

You have:

• Experience with Commercial Quality Control, analytical development, or a related laboratory environment.
• Working knowledge of GMP principles, data integrity expectation of lab data, and applicable procedures and standards in the US and internationally.
• Must be able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories.

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