Principal Scientist, Quality Control Lead, Small Molecules

Gilead Sciences, Inc.•Foster City, CA

48d

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 The Principal Scientist, Quality Control (QC) Lead will be responsible for the strategic oversight and operational execution of cGMP analytical testing in support of small molecule clinical development programs. The role provides leadership for assigned programs across a range of QC activities, ensuring that testing, documentation, and data integrity standards meet regulatory requirements and project deliverables. The ideal candidate will bring deep technical expertise in analytical chemistry and cGMP operations, a strong understanding of phase-appropriate quality control strategies and requirements, and the ability to collaborate cross-functionally to enable successful delivery of clinical supply and development milestones.

Requirements

PhD or PharmD in a related field with 5+ years of experience
OR
Master's Degree with 8+ years of experience
OR
Bachelor's Degree with 10+ years of experience
OR
Associate's Degree with 12+ years of experience
OR
High School Degree with 14+ years of experience

Nice To Haves

10 + years of hands-on and leadership experience in small molecule pharmaceutical analytical testing and quality control.
Prior experience establishing analytical specifications and authoring CMC sections of regulatory submissions.
Deep understanding of regulatory and phase-appropriate QC expectations for clinical development.
Demonstrated experience managing testing activities at external testing laboratories.
Excellent scientific judgement, communication, cross-functional collaboration, and influencing skills.
Demonstrated ability to organize, plan, and execute multiple tasks with flexibility for changing priorities and plans.
Must think critically and creatively and be able to work independently to determine appropriate strategy and resources for resolution of problems
Knowledge of medical devices and combination products.

Responsibilities

Define, implement, and continuously improve the QC strategy for small molecule clinical development programs in alignment with overall CMC and quality objectives.
Serve as the point of contact for overall QC activities including method validation and transfer, reference materials, specifications, cGMP release testing, stability strategy and testing, and supervision of testing at external contract testing laboratories.
Develop and maintain phase-appropriate QC strategies and processes to support manufacturing and regulatory submissions
Responsible for the management and approval of specifications, collaborating cross-functionally to establish scientifically sound and phase-appropriate specifications aligned with analytical capability, process understanding, and clinical and regulatory expectations
Represent QC on cross-functional product development teams, providing technical input and direction for analytical and quality decisions.
Identify and drive opportunities for improvement in QC testing, workflows, data management, and compliance processes.
Proactively identify and escalate potential QC risks, and communicate QC activities, risks, and issues to relevant stakeholders
Oversee and ensure compliant execution of QC testing for raw materials, intermediates, drug substance, and drug product
Ensure timely creation, review, and approval of QC documentation including test methods, protocols, reports, CoAs, and quality records
Provide QC oversight to contract testing laboratories, coordinating testing activities for on-time delivery and confirming compliance with cGMP and data integrity expectations
Direct and oversee timely resolution of QC testing related investigations with comprehensive root-cause analysis, risk assessment, and effective CAPAs
Ensure QC operations comply with cGMP, FDA, EMA, ICH, and other applicable regulations.
Drive excellence in data integrity, documentation practices, and traceability across QC activities
Serve as a QC subject matter expert to draft and review CMC sections and supporting documents for regulatory filings and response to questions (RTQs).
Partner closely with Analytical Development, Manufacturing, Quality Assurance, Regulatory, and Supply Chain to ensure seamless coordination of analytical strategy and QC testing support throughout the product lifecycle
Support technology transfer and method implementation at internal and external laboratories
Provide QC input into product development and regulatory submission documentation

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.
For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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