Senior Research Associate, Analytical Operations

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