Job Abstract

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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
 

The  Research Scientist, Biologics Pre-Pivotal Formulation and Process Development role is part of the collaborative and interdisciplinary CMC development team aiming to use state-of-the art technologies and innovative methodologies to advance medicines into the clinic. The success candidate is expected to bring relevant technical expertise, contribute to key functional strategies, and serve as drug product leads on PDM (Pharmaceutical Development & Manufacturing) project teams. S/he will have opportunities for career growth through acquisition of new skills, experiences, and professional relationships in a fast-paced and resource-rich environment.

Responsibilities: 

• Design and execute formulation and drug product process development work packages, including molecular assessment, First-in-Human formulation development, Drug Product manufacturing process development, and clinical in-use evaluations.
• Drive innovation and continuously grow technical expertise; influence internally and externally through publication, presentations, and industrial collaboration representation.
• Demonstrate understanding of analytical, biophysical characterization, or process development techniques; bring new capabilities; lead by example for lab executions
• Fully embrace data integrity and good documentation practices for data and report generation; critically review internal and external documentation.
• Authors technical documents such as protocols, reports, regulatory dossier, etc  for internal and external audience.
• Effectively collaborates with both internal and external stakeholders in project meetings.
• Support or represent function and work collaboratively on cross-functional teams to support project team strategy and regulatory filings.
• Support and contribute to department initiatives or cross-functional projects to drive business process excellence and scientific innovation.
• May coach direct reports.

Qualifications: 

• Ph.D. in Pharmaceutical Science, Chemistry, Biochemistry, Chemical Engineering, or related scientific fields with 0+ years, M.S. with 6+ years, or B.S. with 8+ years of industrial experience in biologics CMC development.
• Hands-on laboratory experience required.
• Experience with formulation development, Drug Product process development, and clinical in-use evaluation for monoclonal antibodies, bispecifics, antibody-drug conjugates, fusion proteins, and other complex biologics formats strongly desired.
• Publications, external presentations, and the desire to innovate through research strongly preferred.

Gilead Core Values

• Integrity (Doing What’s Right)
• Inclusion (Encouraging Diversity)
• Teamwork (Working Together)
• Excellence (Being Your Best)
• Accountability (Taking Personal Responsibility) 

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.

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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.

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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

Please log onto your Internal Career Site to apply for this job.