Senior Biologics Upstream Process Scientist

MSD UK; West Point (PA); On-site; USD 117,000 - 184,000; Full time

Job summary

Merck & Co., Inc., Rahway, NJ, USA, seeks a science-led professional to support late-stage and commercial cell bank programs for biologics/vaccines. You will drive cell bank process transfers, investigations, data analysis, and regulatory documentation, coordinating with internal and external partners across the network.

The role emphasizes technical leadership, standardization, and collaboration to advance licensure and commercialization while maintaining safety and compliance.

Qualifications

• Cell line development and culture growth metabolism understanding.
• Mammalian and/or microbial cell culture with growth, enumeration, expansion.
• DOE, statistical data analysis, and presentation of results.

Responsibilities

• Direct projects on cell bank process risk assessments and technology transfer.
• Plan and execute work to support commercialization of working cell banks.
• Design and perform lab experiments to generate high quality data.
• Collaborate with research and manufacturing teams to deliver docs and support tech transfer.
• Author regulatory and technical documentation for transfer and licensure.
• Provide leadership across programs and standardize best practices.
• Lead accelerated timelines with safety and compliance.

Skills

Cell Cultures

cGMP Regulations

Biologics

Biology

Process Development

Upstream Processing

Design of Experiments

Regulatory Submissions

Technology Transfer

Chromatographic Techniques

Chemical Engineering

Process Scale Up

Mammalian Cell Culture

Education

Bachelor’s Degree in Biochemistry/Bioengineering/Biochemical Engineering/Biological Engineering

Master’s Degree in Biochemistry/Bioengineering/Biochemical Engineering/Biological Engineering

Ph.D. in Biochemistry/Bioengineering/Biochemical Engineering/Biological Engineering

Job description

Merck & Co., Inc., Rahway, NJ, USA, seeks a science-led professional to support late-stage and commercial cell bank programs for biologics/vaccines. You will drive cell bank process transfers, investigations, data analysis, and regulatory documentation, coordinating with internal and external partners across the network.

The role emphasizes technical leadership, standardization, and collaboration to advance licensure and commercialization while maintaining safety and compliance.