Senior Research Associate, Analytical Operations

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.

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 Senior Research Associate within Analytical Operations at Gilead you will help support expanded capacity for clinical OSD manufacturing.

Responsibilities:

• 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 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.

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

• Perform verification and data review to ensure compliance to appropriate Standard Operating Procedures (SOPs), test methods, specifications, and protocols

• 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.

• 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

Requirements:

• 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

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

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

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