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

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 Scientist, Cell Culture Process Development (Pre-Pivotal) will lead and execute cell culture process development for Gilead biologics entities during pre-pivotal phases development (pre-clinical, phase I/II), including experimental design, laboratory execution, and process transfer. 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 and support general laboratory upkeep.
• Author and review experimental protocols and reports.
• Ensure high-quality, timely documentation in electronic laboratory notebooks and reports.
• Contribute to internal knowledge management and adhere to data protection policies.
• 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.

Basic Qualifications/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).

Preferred Qualifications/Skills/Experience:

• Hands-on laboratory operations experience including shake flask, high-throughput bioreactor, bench scale bioreactor in parallel operation.
• Experience in pre-pivotal stage mammalian cell culture process development and implementation in GMP facilities.
• Experience with process scale-up to pilot and manufacturing scale equipment.
• Understanding of FDA, EMA, and ICH regulatory guidelines related to cGMP.
• 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).
• Understanding or experience with lab automation (e.g. DeltaV, PLC), data modelling and management (e.g. ETL, relational database design, SQL), data science (e.g. time-series forecasting, mechanistic modelling), and programming/scripting (e.g. Python, R).
• 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