Principal Scientist, Analytical Lifecycle Management

Requirements

• PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, Biological Sciences, or a related scientific discipline and 5+ years of relevant experience; OR
• Master's Degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biological Sciences, or a related scientific discipline and 8+ years of relevant experience; OR
• Bachelor's Degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biological Sciences, or a related scientific discipline and 10+ years of relevant experience.
• Preferred:
• Extensive experience in Quality Control, Analytical Development, or CMC technica

Benefits

Additional Information

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 an Principal Scientist, Analytical Lifecycle Management , you will serve as the Quality Control lead for late-stage biologics programs, acting as the primary QC representative on cross-functional Chemistry, Manufacturing, and Controls (CMC) teams. This role is accountable for developing and driving integrated QC strategies throughout the product lifecycle. The position requires strong scientific and regulatory judgment, cross-functional influence, and the ability to translate complex QC topics into clear recommendations that support registration and commercialization readiness. Analytical Lifecycle Management Job Responsibilities: Serve as the QC Lead for late-stage clinical biologics programs, acting as the primary QC representative and accountable strategic point of contact on cross-functional CMC teams. Independently provide QC leadership, technical direction, and risk-based decision-making to advance biologics drug substance and drug product programs toward late-stage development, registration, and commercialization readiness. Own and drive integrated QC program strategy across analytical method establishment, qualification and validation, method transfer, specification setting, stability and shelf-life strategy, reference standard strategy, critical reagent planning, and overall analytical control strategy. Lead authorship, technical review, and strategic input for QC-related sections of regulatory submissions and health authority responses, ensuring scientific rigor, consistency with product strategy, and alignment with global GMP and regulatory expectations. Provide oversight of external partners, such as Contract Development and Manufacturing Organizations (CMDOs) and Contract Testing Laboratories (CTLs), including method readiness, testing execution, data quality, laboratory investigations, quality events, and alignment with program objectives. Anticipate, evaluate, and resolve complex technical, quality, and compliance issues where precedent may be limited, using sound scientific judgment, cross-functional influence, and risk-based decision-making. Influence strategic outcomes across functions by translating complex QC topics into clear recommendations, building alignment among senior stakeholders, and driving timely decisions in support of critical program milestones. Provide technical mentorship, coaching, and guidance to matrixed colleagues and program team members, fostering scientific rigor, accountability, collaboration, and high-quality execution of QC deliverables. Provide strategic oversight of laboratory-based activities as needed, including technical troubleshooting, method readiness assessments, testing strategy, and interpretation of data supporting program decisions.

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