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.

The salary range for this position is: $82,195.00 - $106,370.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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*.
For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact
ApplicantAccommodations@gilead.com
for assistance.
For more information about equal employment opportunity protections, please view the
‘Know Your Rights’
poster.

• 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