Research Associate, Analytical Ops

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

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide.

Role

Summary:

We are seeking a highly motivated, attentive, and self-driven candidate to join the Method Validation and Transfer team in Global Small Molecules. The successful candidate will contribute to the method validation of drug substance, drug product intermediate and drug product to support early phase clinical projects. The candidate will have opportunities for career growth through acquisition of new skills, experiences, and GMP knowledge in a fast-paced and resource-rich environment.

The ideal candidate is expected to be action oriented and should possess good verbal and written communication and interpersonal skills.

Key responsibilities:

Conducts method validation and transfer experiments with guidance for clinical drug substances and products.

Conducts GMP testing for release and stability of clinical drug substances and products using various analytical techniques (e.g. Karl Fisher, Chromatography and Dissolution).

Applies knowledge and complies with GMP in daily activities.

Performs regulatory filing analytical data verification to ensure data integrity.

Conducts experiments for troubleshooting failures/investigations under supervision.

Supports method transfer to qualify CMOs/CTLs for release and stability testing.

Escalates issues and risks to the manager and stakeholders, as applicable.

Basic Qualifications:

BS or BA degree in Chemistry, Biology or relevant science/engineering majors with 0-2 years of relevant experience in biotech/pharmaceutical experience.

Hands-on laboratory experience required.

Preferred Qualifications:

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. Veeva)

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.

Job Description

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…