Associate Principal Scientist, Upstream Process Development

Merck•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. It works with Discovery, Pre-clinical and Early Development to develop processes for diverse biotherapeutics and manufacture clinical-trial material, and leads late-stage process development and characterization in preparation for commercial manufacturing. The organization also partners with Manufacturing to commercialize and launch new products. The Associate Principal Scientist joins the Upstream Process Development team and contributes to CMC development of the company’s pipeline. The role includes designing, developing, and optimizing cell culture processes and transferring processes to clinical and commercial manufacturing sites. The successful candidate is expected to provide scientific leadership, collaborate across functions, communicate effectively, manage multiple priorities, maintain external scientific engagement, and mentor junior staff.

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 experience with mammalian cell culture and fed-batch processes for producing recombinant proteins.
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, 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.
Accomplishments in upstream process and technology development, with a strong scientific publication and presentation record.
Excellent verbal and written communication, interpersonal, and organizational 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.
Ability to work productively and efficiently in a 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 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/down, and technology transfer to GMP manufacturing sites.

Responsibilities

Participate in and/or lead upstream process development for first-in-human and commercial processes, efficiently developing high-yield, robust, and scalable cell culture processes.
Conduct 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 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 advance development, innovation, and adoption of new process technologies.
Keep current with external 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.