Scientist, Cell Culture Process Development - Pre-Pivotal Biologics CMC Development

Gilead Sciences, Inc.; Foster City (CA); On-site; USD 146,000 - 190,000; Full time

Job summary

An established industry player is seeking a passionate Scientist for Cell Culture Process Development. This role involves leading laboratory experimentation for biologics entities during pre-pivotal phases, ensuring high-quality documentation, and mentoring junior team members. The ideal candidate will have a strong educational background in a relevant scientific discipline and hands-on experience in laboratory operations. Join a dynamic team that values collaboration and innovation, and contribute to groundbreaking therapies that improve lives globally. This is an exciting opportunity to make a significant impact in a forward-thinking organization committed to health advancements.

Benefits

Discretionary annual bonus

Stock-based long-term incentives

Paid time off

Company-sponsored medical insurance

Dental insurance

Vision insurance

Life insurance

Qualifications

• PhD or M.S. in relevant scientific discipline with hands-on lab experience.
• Experience in pre-pivotal cell culture process development and GMP implementation.

Responsibilities

• Lead and execute cell culture process development laboratory studies.
• Mentor junior team members and ensure high-quality documentation.

Skills

Laboratory Operations

Cell Culture Process Development

Technical Writing

Creative Problem Solving

Collaboration

Data Analysis

Education

PhD in relevant scientific discipline

M.S. with 4+ years of experience

B.S. with 6+ years of experience

Tools

JMP

Spotfire

Job description

Scientist, Cell Culture Process Development - Pre-Pivotal Biologics CMC Development

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

Scientist, Cell Culture Process Development - Pre-Pivotal Biologics CMC Development – Foster City, CA

The Senior Associate Scientist, Cell Culture Process Development (Pre-Pivotal) will lead and execute cell culture process development laboratory experimentation for Gilead biologics entities during pre-pivotal phases development (pre-clinical, phase I/II). He/she will also lead and execute laboratory experimentation for cell culture process technology development, platform process evolution initiatives, and will support implementation in internal and external GMP facilities.

Key Responsibilities:

• Plan and execute cell culture process development laboratory studies and support process implementation in internal and external GMP facilities.
• Provide technical support for GMP operations.
• Establish and maintain a state-of-the-art cell culture process development laboratory.
• Lead studies for cell culture process technology development and platform process evolution projects for increased productivity, high quality product, and speed to clinic.
• Contribute to design of and conduct laboratory scale experiments; hands-on laboratory execution is expected, including weekends.
• Maintain cell culture laboratory equipment and supplies.
• Author and review experimental protocols and reports.
• Ensure high-quality, timely documentation in electronic laboratory notebooks and reports.
• Collect and analyze data from laboratory experiments.
• Travel as required to support technology transfers and provide oversight at external manufacturing facilities.
• 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 as needed.

Qualifications/Skills/Experience:

• PhD with 0+ years OR M.S. with 4+ years OR B.S. with 6+ years 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: $146,540.00 - $189,640.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, 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.