Senior Scientist, Engineering

MSD•Rahway, NJ

3d•$117,000 - $184,200

About The Position

The Senior Scientist, Engineering works in the Chemical Commercialization Technology (CCT) department within the manufacturing division. The role uses scientific and technical expertise to develop safe, robust manufacturing processes for late-stage small-molecule pipeline projects, including process characterization, technology transfer, validation, regulatory filing, and supply support. A central focus is optimizing and characterizing enzyme manufacturing process controls across scales, drawing on expertise in microbial fermentation and downstream processing. The position includes hands-on experimentation at laboratory bench and kilo lab scales, technology transfers to commercial manufacturing facilities, and support for internal technical capability development. The scientist mentors junior staff and helps enhance fermentation and downstream processing laboratory capabilities. The role also requires a strong safety and quality mindset, including adherence to current Good Manufacturing Practices (cGMPs) and participation in risk assessments, deviation investigations, and Good Documentation Practices (GDPs). The position is based primarily in Rahway, New Jersey, has a first-shift schedule, and requires 10% travel. No relocation is offered.

Requirements

PhD in Chemical Engineering, Bioprocess Engineering, Biological Engineering, Synthetic Biology, or a related field from an accredited college or university.
At least three years of experience in chemical, pharmaceutical, large-molecule, or vaccine process development.
Experience and knowledge in microbial fermentation and downstream process development and optimization, as well as process scale-up and scale-down.
Demonstrated capability to develop and execute experimental programs addressing process design, robustness, and productivity.
Experience with process scale-up and technology transfer from a laboratory to a pilot plant or factory.
Ability to mentor technical staff in the laboratory and through data analysis.
Highly effective communication and collaboration skills.
Good organizational, interpersonal, writing, and time-management skills.

Nice To Haves

Experience conducting laboratory-based research or process development, including small-molecule drug substance unit operations such as chemical reactions, work-up, and crystallization.
Experience leading filing authoring, validation planning, and execution.
Experience guiding internal and external technical discussions.
Familiarity with statistical design and analysis tools.
Familiarity with cGMP concepts and application, ideally during pharmaceutical drug substance or drug product development and production in a pilot or factory setting.
Experience with mathematical modeling, theoretical scaling calculations, and Quality by Design (QbD) principles.
Experience supporting or writing regulatory filings.

Responsibilities

Develop safe and robust manufacturing processes through process characterization, technology transfer, validation, filing, and supply support of late-stage small-molecule pipeline projects.
Optimize and fully characterize enzyme manufacturing process control strategies across different scales, drawing on microbial fermentation and downstream processing expertise.
Mentor junior staff and enhance fermentation and downstream processing laboratory capabilities.
Support technology transfers to commercial manufacturing.
Use Quality Risk Management methodologies and statistical design of experiments tools.
Conduct hands-on experimentation at laboratory bench and kilo lab scales.
Maintain safety and quality compliance, including following cGMPs and participating in risk assessments, deviation investigations, and GDP practices.
Lead and operate within a cross-functional process development team.