Associate Principal Scientist, Upstream Process Development

MSD•Rahway, NJ

2d•$142,400 - $224,100•Onsite

About The Position

The Biologics Process Research & Development organization develops drug substance manufacturing processes for the company's biologics pipeline, supporting both early clinical supply and preparation for commercial manufacturing. It collaborates with Discovery, Pre-clinical and Early Development, and Manufacturing colleagues to develop, characterize, transfer, commercialize, and launch biologics processes. The Associate Principal Scientist joins the Upstream Process Development team and contributes to CMC development by designing, developing, and optimizing cell culture processes and transferring them to clinical and commercial manufacturing sites. The role calls for scientific leadership, effective organization and multitasking, strong communication and cross-functional collaboration, external scientific engagement, and mentoring of junior staff. The position is based primarily in Rahway, New Jersey. The stated base salary range for that location is $142,400 to $224,100, with eligibility for an annual bonus and long-term incentive, if applicable. The role is regular employment, offers domestic relocation, and provides visa sponsorship. Travel requirements are 10%.

Requirements

Ph.D. with at least 4 years of experience, or a Master's degree with at least 8 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 systems.
Working knowledge of statistical methods, including design of experiments and multivariate data analysis, and tools such as SIMCA and JMP.
Understanding of cell culture bioreactors, including microbioreactors and bench- and pilot-scale bioreactors, and scale-up principles from laboratory to large scale.
Track record of accomplishments in upstream process and technology development, with scientific publications and presentations.
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 an organized manner.
Excellent verbal and written communication and interpersonal skills.
Ability to work effectively in cross-functional, matrixed teams and collaborate with internal and external partners, including vendors.
Initiative, creativity, and innovation in problem solving.
Productivity and efficiency in laboratory work.
Ability to deliver complex objectives under aggressive timelines.
Proficiency in bioreactor simulation and modeling.

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 integration of 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 GMP manufacturing sites.

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.
Lead process development, process characterization, and regulatory filing activities to support successful PPQs and BLAs for the company’s pipeline.
Partner with Discovery, Cell Line, Downstream Process Development, Analytical Sciences, and Manufacturing colleagues 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 develop, innovate, and adopt new process technologies.
Keep current with external scientific literature; present and publish externally and pursue patenting strategies.
Plan, execute, analyze, and document all stages of cell culture process development.
Plan, execute, analyze, and communicate complex and critical data in an organized manner.
Contribute scientific leadership, cross-functional collaboration, and mentoring of junior staff.