Research Associate, Analytical Ops

Gilead People Leader

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.

Specific Job Responsibilities:

• Conduct GMP testing for release, stability, and method transfer for clinical drug substances and products.
• Conduct GMP testing for raw materials, raw material intermediates, in-process control, and cleaning samples in support of pilot plant manufacturing
• Analyze samples using various analytical techniques such as Ultra-Performance Liquid Chromatography/High-Performance Liquid Chromatography (UPLC/HPLC), Gas Chromatography, Ion Chromatography, Dissolution, Karl Fischer, Differential Scanning Calorimetry, Particle Size Distribution, X-Ray Powder Diffraction, UV-Vis spectroscopy, etc.
• Perform verification and data review to ensure compliance to appropriate Standard Operating Procedures (SOPs), test methods, specifications, and protocols
• Perform stability data trending, conduct laboratory investigations for suspect results, and troubleshoot instruments and test methods
• Author/Review laboratory investigation records (issues and investigations), deviations, and Corrective and Preventive Action (CAPA)
• Provide on-the-job training of analytical techniques or other Good Manufacturing Practice (GMP) training to new hires or junior staff
• Write/Revise protocols, methods, SOPs, reports, etc.
• Participate in laboratory housekeeping activities and report any concerns to a laboratory lead and/or manager
• Lead projects and support cross-functional activities (e.g., instrument/system upgrade activities, method validation, etc.)
• 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

Specific Education & Experience Requirements: BA or BS in Chemistry or Biology with 0+ years industry experience.

The salary range for this position is: $82,195.00 - $106,370.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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*.

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