Senior Research Associate I, Analytical Development and Operations

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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
 

Senior Research Associate I, Analytical Development and Operations

(Method Validation Transfer Group)

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines. With the commitment and drive you bring to the Pharmaceutical Development & Manufacturing (PDM) workplace, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives.

This role is in the Analytical Development & Operations (ADO) group within Technical Development (TD), based at our headquarters in Foster City, CA. The group is responsible for CMC analytical activities related to the validation and transfer of Gilead’s small molecule drug substances and drug products. The successful candidate will possess an understanding of analytical method development, validation/transfer, GMP testing with strong critical thinking skills, and excellent communication skills.

Essential Duties and Job Functions:

• Write and review validation plans and validation protocols.

• Independently conduct research and development work

• Execute GMP method validation of drug substance, drug product intermediate and drug product samples based on written procedures.

• Familiar with laboratory techniques such as Karl Fischer, Dissolution, Liquid Chromatography (LC), Gas Chromatography (GC), Ion Chromatography (IC), Particle Size (PSD), and UV-Vis spectroscopy.

• Work with team members to design experiments, troubleshoot instruments and test methods.

• Author and revise test methods, technical reports, SOPs and compliance documents.

• Review data to ensure compliance according to test methods, specifications, and protocols.

• Participate in user requirements, assessment and validation of 21 CFR Part 11 software and/or customized software.

• Apply knowledge of current Good Manufacturing Practices (cGMPs).

• Participate in meetings, present results and interpret data.

• Be an effective communicator of ideas and results to team members across cross-functional roles/departments. Proactively identify issues, develop solutions and conduct investigations in a collaborative multidisciplinary environment.

• Work with Regulatory Affairs & Quality Assurance to ensure that all applicable FDA regulations are followed.

Education and Experience:

• Bachelors degree in Chemistry, Biology or relevant science majors with 2+ years of relevant biotech/pharmaceutical experience; or Masters degree with 0+ years of relevant biotech/pharmaceutical experience.

• Excellent verbal and written communication skills.

• Hands-on proficiency and problem-solving skills with UPLC/HPLC, GC, IC, Dissolution, KF titration, Particle Size Distribution, or other analytical techniques.

• Strong working knowledge of cGMP and Quality Control (QC).

• Knowledge of Lab information System and Part 11 software (e.g. Empower, Electronic Lab Notebook, SDMS).

 

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 considera