Principal Scientist, Analytical Operations

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 Principal Scientist, Analytical Operations at Gilead you will act as a 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.

FOCUS AREAS

Quality Control Leadership & Strategy

• 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

Analytical Testing & Documentation

• 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

Compliance & Regulatory Affairs

• 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).

Cross-Functional Collaboration

• 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

REQUIREMENTS & QUALIFICATIONS

You have:

• 10+ years’ experience with a BS OR
• 8+ Years’ experience with a MS, OR
• 5+ years' experience with a PHD or PharmD in a related field
• Significant knowledge and hands-on and leadership experience in small molecule pharmaceutical analytical testing and quality control.
• Experience in parenterals, medical device and combination products
• 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

People Leader Accountabilities:

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.