Sr Scientist, Quality Control Lead, Small Molecules
Base pay range: $169,320.00 – $219,120.00 per year.
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. Our mission requires collaboration, determination and a relentless drive to make a difference.
Job Description
The Sr 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 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.
- Manage and approve 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 elevate 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 responses 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.
Basic Qualifications
PhD or PharmD in a related field with 2+ years of experience OR Master’s Degree with 6+ years of experience OR Bachelor’s Degree with 8+ years of experience OR Associate’s Degree with 10+ years of experience OR High School Degree with 12+ years of experience.
Preferred Qualifications
- 8+ 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.
- Strong understanding of regulatory and phase‑appropriate QC expectations for clinical development.
- Demonstrated experience managing testing activities at external testing laboratories.
- Excellent scientific judgment, 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 is a plus.
Salary and Benefits
In addition to base pay, the position may also be eligible for a discretionary annual bonus, discretionary stock‑based long‑term incentives (eligibility may vary), paid time off and a benefits package including company‑sponsored medical, dental, vision and life insurance plans. For further benefits information, visit Gilead Compensation & Benefits .
Gilead Core Values
- Integrity (Doing What’s Right)
- Inclusion (Encouraging Diversity)
- Teamwork (Working Together)
- Excellence (Being Your Best)
- Accountability (Taking Personal Responsibility)
Equal Employment Opportunity Statement
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information, gender identity and expression, veteran status or other non‑job related characteristics, in accordance with applicable federal, state and local laws. Applications requiring accommodations may contact for assistance.
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