Research Associate, Analytical Ops

Descripción del trabajo

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.