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Senior Research Scientist I, Biologics Pre-Pivotal Formulation and Process Development

United States - California - Foster CityProcess/Product Development & OperationsRegular

Descripción del trabajo

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.


We empower our leaders to step up, share ideas, listen, learn, and lead. We’re welcoming bright, diverse, and imaginative minds; we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.


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. Join Gilead and help create possible, together.

Job Description

The Senior Research Scientist I, 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 deep 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 documentations.
  • Represent function and work collaboratively on cross-functional teams to support project team strategy and regulatory filings.
  • Lead initiative teams to drive for business process excellence and scientific innovation.
  • May coach direct reports.

Qualifications:

  • Ph.D. in Pharmaceutical Science, Chemistry, Biochemistry, Chemical Engineering, or related fields with 2+ years, M.S. with 8+ years, or B.S. with 10+ years of industrial experience in biologics CMC development.
  • Extensive 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; experience of IND filings.
  • Hands-on in lab execution and has experience of training junior members.
  • Publication and external presentation track records demonstrating strong technical innovation capabilities and industrial influence.
  • Lyophilization cycle development, GMP drug product fill and finish, lab automation and data science experience and expertise is highly desired.
  • People leading experience is strongly desired.
  • Experience working with contracted organization is highly preferred.

Gilead Core Values

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

The salary range for this position is: $177,905.00 - $230,230.00. 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:

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.

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