Lead Scientist, Upstream Biologics Process Development

MSD Malaysia; Rahway (NJ); On-site; USD 142,000 - 224,000; Full time

Job summary

Merck & Co., Inc. in Rahway, NJ seeks an Associate Principal Scientist to lead upstream process development for mammalian cell culture and commercial scale-up. The role partners across Discovery, Downstream, Analytics, and Manufacturing to drive CMC development, design experiments, and transfer optimized processes to clinical and manufacturing sites.

The candidate will have a Ph.D. with 4+ years or a related Master’s with 8+ years in chemical/biological engineering, hands-on CHO culture and

Qualifications

• Ph.D. with 4+ years’ experience or Master’s with 8+ years’ experience in chemical engineering, bioengineering, biological engineering, or a related field.
• Hands-on mammalian cell culture and fed-batch processes to produce recombinant proteins.
• Strong knowledge of CHO biology, metabolism, and large-scale culture.
• Experience with DoE and multivariate data analysis tools (e.g., SIMCA, JMP).

Responsibilities

• Lead upstream process development of first-in-human and commercial cell culture processes with high yield and scalability.
• Oversee process characterization, regulatory filing activities for PPQ and BLA.
• Collaborate with Discovery, Cell Line, Downstream, Analytics, and Manufacturing for integrated processes.
• Drive improvements to increase operational efficiency and reduce costs.
• Mentor junior staff and publish externally to share advances.

Skills

Mammalian cell culture

Fed-batch processing

CHO cell biology

Design of experiments

Multivariate data analysis

Bioreactor scale-up

Publication record

Cross-functional collaboration

Communication skills

Problem solving

Education

Ph.D. in Chemical/BioEngineering

Master's in Chemical/BioEngineering

Tools

SIMCA

JMP

Job description

Merck & Co., Inc. in Rahway, NJ seeks an Associate Principal Scientist to lead upstream process development for mammalian cell culture and commercial scale-up. The role partners across Discovery, Downstream, Analytics, and Manufacturing to drive CMC development, design experiments, and transfer optimized processes to clinical and manufacturing sites.

The candidate will have a Ph.D. with 4+ years or a related Master’s with 8+ years in chemical/biological engineering, hands-on CHO culture and