Senior Research Associate, Analytical Operations

About the Role

As a Senior Research Associate within Analytical Operations at Gilead, you will support expanded capacity for clinical OSD manufacturing. You will conduct GMP testing, analyze samples with a range of analytical techniques, and lead cross-functional projects to ensure compliance and timely delivery of clinical materials. You will serve as a subject-matter expert and contribute to continuous improvement and regulatory readiness. What You'll Do

• Conduct GMP testing for raw materials, raw material intermediates, in-process control, and cleaning samples in support of pilot plant manufacturing

• Test method feasibility for drug product pilot plant cleaning samples

• Analyze samples using analytical techniques such as UPLC/HPLC, Gas Chromatography, Ion Chromatography, Dissolution, Karl Fischer, DSC, Particle Size Distribution, X-Ray Powder Diffraction, UV-Vis spectroscopy, etc.

• Participate in laboratory housekeeping activities and report concerns to a laboratory lead and/or manager

• Perform verification and data review to ensure compliance to SOPs, test methods, specifications, and protocols

• Author/Review laboratory investigation records (issues and investigations), deviations, and CAPA

• Provide on-the-job training of analytical techniques or other GMP training to new hires or junior staff

• Write/Revise protocols, methods, SOPs, reports, etc.

• Lead projects and support cross-functional activities (e.g., instrument/system upgrade activities, method validation, etc.)

• Conduct GMP testing for release, stability, and method transfer for clinical drug substances and products

• Serve as a Subject Matter Expert in analytical techniques or processes, participate in working groups, assess pharmacopeial changes, and support internal audits and regulatory inspections, as appropriate What We're Looking For

• Bachelor's Degree in Chemistry, Biology or related field and 2+ years of experience OR Masters Degree in Chemistry, Biology or related field with 0+ industry experience

• Strong knowledge of analytical techniques and GMP requirements

• Ability to author/review laboratory investigations, deviations, and CAPA

• Experience with instrument validation, method validation, and method transfer

• Excellent communication and cross-functional collaboration skills

• Commitment to compliance with SOPs and quality systems Nice to Have

• Experience serving as a Subject Matter Expert and participating in audits/regulatory inspections

• Knowledge of pharmacopeial changes and regulatory expectations Compensation & Benefits

• Salary range: $94,945.00 - $122,870.00 per year

• Eligible for discretionary annual bonus and discretionary stock-based long-term incentives (eligibility may vary by role)

• Benefits include paid time off, and company-sponsored medical, dental, vision, and life insurance plans

• For additional benefits information, please refer to the Gilead careers compensation, benefits, and wellbeing information