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

Descrizione del lavoro

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.