Senior Research Associate I

For Current Gilead Employees and Contractors:

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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
 

Essential Duties and Job Functions:

• Independently conduct GMP routine analysis following written procedures using analytical techniques such as appearance, water content, dissolution, disintegration, High Performance Liquid Chromatography, Ultra Performance Liquid Chromatography (UPLC / HPLC), Differential Scanning Calorimetry (DSC), particle size, X-ray Powder Diffraction (XRPD), and UV-Vis spectroscopy, etc.
• Apply knowledge of current Good Manufacturing Practices (cGMPs) on a daily basis
• Perform verification and data review of routine testing to ensure compliance to appropriate test methods, specifications, and protocol
• Perform stability data trending
• Independently write LI-Issues
• Support laboratory investigations and deviations
• Write and revise protocols, methods, Standard Operating Procedures (SOPs), and reports with guidance
• Participate in group meetings.  May present data or prepare information for others to present
• Provide on-the-job training of physical testing techniques (e.g., water content, DSC, XRPD, Particle Size, etc.) to new hires or junior staff
• Provide technical support for compendial review program as needed
• Conduct non-routine analysis based on written procedures (e.g. investigations, validation, transfer, etc.)
• Troubleshoot instrumentation and test methods
• Support internal audits regulatory inspections as needed
• Generate functional performance metrics for management review
• Managing inventory for reagents, columns and perform routine lab clean up

Knowledge and Skills:

• Hands-on experience with analytical techniques such as High Performance Liquid Chromatography, Ultra Performance Liquid Chromatography (HPLC/UPLC), Dissolution, Karl Fischer Titration, Gas Chromatography (GC), Differential Scanning Calorimetry, Thermogravimetric Analysis (DSC/TGA), particle size, X-ray Powder Diffraction (XRPD), disintegration, etc.
• Have technical and laboratory skills to execute analyses efficiently and reliably in GMP regulated analytical laboratories
• General understanding of industry standards, cGMPs, quality control (QC), and pharmacopeias 
• Working knowledge in Lab information system and software (e.g. Electronic Lab Notebook (ELN), Laboratory Information Management System (LIMS), Laboratory Execution System (LES), Empower, LabX, Scientific Data Management System (SDMS), Veeva Vault (GVault), etc.)
• Demonstrates effective time management skills and ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude
• Ability to clearly and concisely present/articulate testing and analysis results to multiple internal audiences
• Excellent interpersonal skills and ability to work effectively with people from a wide range of skill levels and experience
• Excellent verbal and written communication skills

Education and Experience:

• BS or BA degree in Chemistry, Biology or a related scientific discipline with 2 years OR M.S. degree with 0+ years of relevant experience in biotech/pharmaceutical industry

 

The salary range for this position is: $92,820.00 - $120,120.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean