Senior Principal Scientist, Upstream Bioprocess

The Biologics Process Research & Development organization within our Research & Development Division is responsible for developing the drug substance manufacturing processes for our Company's biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical and Early Development to rapidly develop manufacturing processes for diverse biotherapeutics and efficiently manufacture material to supply clinical trials. We are also responsible for late-stage process development and process characterization to prepare for commercial manufacturing. We work with our partners in our Company Manufacturing Division to commercialize and launch new products.* Technical background and hands-on experience with mammalian cell culture and fed-batch processes to produce recombinant proteins.* Scientific understanding and working knowledge of CHO cell biology, metabolism, cell culture media and engineering principles for large scale recombinant protein production systems.* Working knowledge of statistical methods (design of experiment, multivariate data analysis) and tools (SIMCA, JMP, etc.).* Understanding of cell culture bioreactors including microbioreactors, bench-scale and pilot-scale bioreactors, and bioreactor scale-up principles from laboratory to large scale.* Proven track record of accomplishments in upstream process and technology development with a strong scientific publication and presentation track record.* Ability to direct the planning, execution, analysis, and documentation of all stages of cell culture process development.* Plan, execute, analyze, and communicate complex and critical data in a highly organized manner.* Excellent verbal, written communication, and interpersonal skills.* Ability to work effectively in cross-functional and matrixed team environment; collaborate with both internal and external partners including vendors.* Demonstrated ability for taking initiative, creativity, and innovation in problem solving.* Productivity and efficiency working in the laboratory.* Ability to deliver complex objective under aggressive timelines.* Experience with cell culture media development.* Experience with high throughput microbioreactor systems and advanced in situ analytics for process monitoring and control.* Experience with state-of-the-art cell culture processes including intensified inoculum/fed-batch and perfusion process development.* Background in data science approaches related to cell culture and predictive modeling, e.g. metabolic flux (MFA) analysis, omics, machine learning; computational fluid dynamics, and experience integrating PAT efforts.* Experience with late-stage commercial process development, technology transfer, scale-down model qualification, and process characterization.* Knowledge of biologics CMC development cycle and scale-up/down in addition to tech transfer to GMP manufacturing site.**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance #J-18808-Ljbffr MSD Malaysia