Associate Principal Scientist, Upstream Process Development

MSD • Rahway, NJ

11h

About The Position

The Biologics Process Research & Development organization develops drug substance manufacturing processes for the company’s biologics pipeline, working with Discovery, Pre-clinical and Early Development to develop processes and supply clinical trials. The organization also performs late-stage process development and process characterization in preparation for commercial manufacturing and partners with the Manufacturing Division to commercialize and launch products.

The Associate Principal Scientist will work with scientists and engineers in Upstream Process Development, contributing to CMC development through the design, development, and optimization of cell culture processes and their transfer to clinical and commercial manufacturing sites. The role calls for scientific leadership, strong organization and communication, cross-functional collaboration, external scientific engagement, and mentoring junior staff.

The position includes upstream process development for first-in-human and commercial processes, process characterization and regulatory filing activities, integrated process development with cross-functional partners, improvement of upstream platform processes, and collaboration with external organizations on new process technologies. The successful candidate is expected to keep current with external literature and to present, publish, and pursue 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 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, bench-scale and pilot-scale bioreactors, and scale-up principles from laboratory to large scale.
• Proven accomplishments in upstream process and technology development, with a strong scientific publication and presentation record.
• Ability to direct planning, execution, analysis, and documentation of all stages of cell culture process development.
• Excellent verbal, written, and interpersonal communication skills.
• Ability to work effectively in cross-functional and matrixed teams and collaborate with internal and external partners, including vendors.
• Initiative, creativity, and innovation in problem solving.
• Productivity and efficiency in the laboratory.
• 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 integrating process analytical technology (PAT) 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 or contribute to process development, process characterization, and regulatory filing activities to support successful PPQs and BLAs.
• Partner with Discovery, Cell Line, Downstream Process Development, Analytical Sciences, and Manufacturing colleagues to develop integrated clinical and commercial processes 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 development, innovation, and adoption of new process technologies.
• Keep current with external literature; present and publish externally and pursue patenting strategies.
• Direct planning, execution, analysis, and documentation across all stages of cell culture process development.
• Plan, execute, analyze, and communicate complex and critical data in an organized manner.
• Mentor junior staff and contribute scientific leadership in upstream process development.

Benefits

• Medical, dental, and vision healthcare and other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.
• Annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior