Associate Principal Scientist, Upstream Process Development

MSD•Rahway, NJ

2d•$142,400 - $224,100

About The Position

The Biologics Process Research & Development organization develops drug substance manufacturing processes for the company's biologics pipeline, supporting early clinical supply through late-stage development, process characterization, commercialization, and product launches. The Associate Principal Scientist will work with scientists and engineers in Upstream Process Development to contribute to CMC development, design and optimize cell culture processes, and transfer processes to clinical and commercial manufacturing sites. The role calls for scientific leadership, strong organization and multitasking, excellent communication, cross-functional collaboration, external scientific engagement, and mentoring junior staff. The role involves developing robust, high-yield, scalable cell culture processes; supporting process characterization and regulatory filings; creating integrated manufacturing solutions with partner functions; improving upstream platform processes; and collaborating with external organizations to develop and adopt new technologies. The scientist is also expected to stay current with scientific literature and contribute through external presentations, publications, and patenting strategies.

Requirements

Ph.D. with 4 or more years of experience, or a Master's degree with 8 or more years of experience, in chemical engineering, bioengineering, biological engineering, or a related field.
Hands-on technical experience with mammalian cell culture and fed-batch processes for recombinant protein production.
Scientific understanding and working knowledge of CHO cell biology, metabolism, cell culture media, and engineering principles for large-scale recombinant protein production.
Working knowledge of statistical methods such as design of experiments and multivariate data analysis, and tools such as SIMCA and JMP.
Understanding of cell culture bioreactors, including microbioreactors, bench-scale and pilot-scale bioreactors, and scale-up principles from laboratory to large scale.
Track record of accomplishments in upstream process and technology development, with a strong scientific publication and presentation record.
Ability to direct the planning, execution, analysis, and documentation of all stages of cell culture process development.
Ability to plan, execute, analyze, and communicate complex and critical data in a highly organized manner.
Excellent verbal and written communication, and interpersonal skills.
Ability to work effectively in cross-functional and matrixed teams and collaborate with internal and external partners, including vendors.
Demonstrated initiative, creativity, and innovation in problem solving.
Productivity and efficiency in the laboratory.
Ability to deliver complex objectives under aggressive timelines.
Required skills listed: Cell Line Development, Detail-Oriented, Downstream Process Development, Drug Delivery Technology, Drug Development, Expression Vectors, Interpersonal Relationships, Leading Project Teams, Molecular Biology, Pharmaceutical Formulations, Pharmaceutical Process Development, Physical Characterization, Stable Cell Lines, and Strategic Planning.

Nice To Haves

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, such as metabolic flux analysis, omics, and machine learning; computational fluid dynamics; and experience integrating process analytical technology efforts.
Experience with late-stage commercial process development, technology transfer, scale-down model qualification, and process characterization.
Knowledge of the biologics CMC development cycle, scale-up and scale-down, and technology transfer to a GMP manufacturing site.

Responsibilities

Participate in and/or lead upstream process development for first-in-human and commercial processes, developing high-yield, robust, and scalable cell culture processes.
Conduct process development and characterization and support regulatory filing activities to advance the pipeline toward successful PPQs and BLAs.
Partner with Discovery, Cell Line, Downstream Process Development, Analytical Sciences, and Manufacturing to develop integrated clinical and commercial process and manufacturing solutions that meet quality-by-design targets and use robust control strategies.
Advance upstream platform processes through process improvement initiatives that increase operational efficiency and reduce costs.
Collaborate with academia, industry partners, and vendors to drive process development, innovation, and adoption of new technologies.
Keep current with external literature, present and publish externally, and pursue patenting strategies.
Direct planning, execution, analysis, and documentation of cell culture process development stages.
Plan, execute, analyze, and communicate complex and critical data in an organized manner.
Mentor junior staff.