Sr Research Associate, Analytical Ops

Gilead Sciences • Foster City, CA

20h

About The Position

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

Requirements

• 2+ years of experience with BA or BS degree in Chemistry or Biology.
• MS in Chemistry or Biology with 0+ industry experience.
• Previous experience conducting and analyzing data for analytical methods such as UPLC/HPLC, GC, Dissolution, KF titration, Particle Size Distribution, etc.
• Excellent technical and laboratory skills to execute analyses efficiently and reliably in GMP regulated analytical environments.
• Strong working knowledge of cGMP and quality control (QC).
• Knowledge in Lab information System and Part 11 software (e.g. Empower, Electronic Lab Notebook, SDMS and LIMS) to ensure data integrity rules are followed and documentation are in compliance.
• Knowledge in Compliance System (e.g. GVault)
• Be an effective communicator of ideas and results to team members across cross-functional roles/departments.
• Proactively identify issues and develop solutions in a collaborative multidisciplinary environment.
• 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.

Responsibilities

• Conducts method validation and transfer experiments with limited guidance for clinical and commercial drug substances and products.
• Conducts GMP testing for release and stability of clinical drug substances and products using various analytical techniques.
• Applies knowledge and complies with GMP in daily activities.
• Conducts GMP data review to ensure compliance with applicable Standard Operating Procedures (SOPs), test methods, specifications, and protocols.
• Performs regulatory filing analytical data verification to ensure data integrity.
• Conducts experiments for troubleshooting failures/investigations under supervision
• Authors and reviews analytical test methods
• Supports method transfer to qualify CMOs/CTLs for release and stability testing
• Assists in training QC analysts.
• Escalates issues and risks to the manager and stakeholders, as applicable.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level