Senior Research Scientist I, Cell Culture Process Development - Pre-Pivotal Biologics CMC Development

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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.

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

Senior Research Scientist I, Cell Culture Process Development

• Pre-Pivotal Biologics CMC Development

• Foster City, CA

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, Cell Culture Process Development (Pre-Pivotal) will be responsible for leading aspects of cell culture development including process development and process implementation at internal or external GMP facilities for Gilead biologics entities during pre-pivotal phases development (pre-clinical, phase I/II). He/she will also lead projects for cell culture process technology development, platform process evolution, and cell culture-related regulatory documentation.

Key Responsibilities:

• Lead cell culture process development and implementation in internal and external GMP facilities, as well as technical support of GMP operations.

• Establish and maintain a state-of-the-art cell culture process development laboratory.

• Lead cell culture process technology development and platform process evolution projects for increased productivity, high quality product, and speed to clinic.

• Design and conduct laboratory scale experiments; hands-on laboratory execution is expected.

• Review GMP and non-GMP technical documentation (batch records, SOPs, guidance documents, and reports).

• Ensure high-quality documentation in electronic laboratory notebooks and reports.

• Author relevant sections of regulatory filings and responses to information requests.

• Support investigations and identify root causes for critical deviations.

• Travel as required to support technology transfers and provide oversight at external manufacturing facilities.

• Contribute to business process improvements related to early-stage process development.

• Adhere to department budget and all training, compliance and safety requirements.

• Mentor junior team members on cell culture process development strategies and experimental design and execution.

• Participate on cross-functional initiatives.

Qualifications/Skills/Experience:

• Ph.D. with 2+ years OR M.S. with 8+ years OR 10+ Years with BS experience in a relevant scientific discipline (biology, bioengineering, chemical engineering, biochemical engineering).

• Hands-on laboratory operations experience including shake flask, high-throughput bioreactor, bench scale bioreactor, and pilot scale cultures.

• Experience in pre-pivotal stage cell culture process development and implementation in GMP facilities.

• Excellent communication, technical writing, and presentation skills and aptitude for creative problem solving.

• Demonstrated ability to collaborate and influence cross-functionally.

• Experience in statistics, design-of-experiments, and data analysis (e.g. JMP, Spotfire).

• Working knowledge of lab automation, data management, data science, knowledge management and data protection.

• Passion for inclusion: knowing the business value of diverse teams, modelling inclusion, and embedding the value of diversity in the way he/she works.

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.

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For Current Gilead Employees and Contractors:

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