Principal Scientist, Quality Control Lead, Small Molecules

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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.

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

Basic Qualifications:

PhD or PharmD in a related field with 5 years of experience

OR

Masters Degree with 8 years of experience

OR

Bachelors Degree with 10 years of experience

OR

Associates Degree with 12 years of experience

OR

High School Degree with 14 years of experience

Preferred Qualifications:

• 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.

Gilead Core Values

Integrity (Doing Whats Right)

Inclusion (Encouraging Diversity)

Teamwork (Working Together)

Excellence (Being Your Best)

Accountability (Taking Personal Responsibility)

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

For jobs in the United States:

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