Senior Scientist, Engineering

MSD • Rahway, NJ

2d

About The Position

The Senior Scientist, Engineering works in the Chemical Commercialization Technology (CCT) department within the Manufacturing Division. The role applies scientific and technical expertise to develop safe, robust manufacturing processes and support late-stage small-molecule pipeline projects through process characterization, technology transfer, validation, regulatory filing, and supply support. A particular focus is enzyme manufacturing, requiring expertise in microbial fermentation and downstream processing to optimize and characterize process control strategies across scales.

The successful candidate will help build internal technical capabilities by mentoring junior staff and enhancing fermentation and downstream-processing laboratory capabilities. The work includes hands-on experiments at laboratory bench and kilo-lab scales, as well as transferring technologies to commercial manufacturing facilities. The role also uses Quality Risk Management methodologies and statistical design-of-experiments tools. The candidate is expected to maintain a strong safety and quality-compliance mindset, including adherence to current Good Manufacturing Practices (cGMPs) and Good Documentation Practices (GDPs), and participation in risk assessments and deviation investigations.

This is a regular, first-shift position based in Rahway, New Jersey. Travel requirements are 10%. Relocation is not offered, and visa sponsorship is not available.

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 ability to develop and execute experimental programs addressing process design, robustness, and productivity.
• Experience with process scale-up and technology transfer from laboratory to pilot plant or factory.
• Ability to mentor technical staff in laboratory work and data analysis.
• Highly effective communication and collaboration skills.
• Good organizational, interpersonal, writing, and time-management skills.
• Ability to lead and work within a cross-functional process-development team.

Nice To Haves

• Laboratory research or process-development experience performing unit operations common in small-molecule drug-substance process development, 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 current Good Manufacturing Practices (cGMPs), ideally in 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 for late-stage small-molecule pipeline projects.
• Optimize and 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 tools for statistical design of experiments.
• Conduct hands-on experimentation at laboratory bench and kilo-lab scales.
• Maintain safety and quality compliance, including following current Good Manufacturing Practices (cGMPs) and Good Documentation Practices (GDPs), and participating in risk assessments and deviation investigations.
• Lead and operate within a cross-functional process-development team.

Benefits

• Medical, dental, and vision healthcare benefits.
• Other insurance benefits for employees and their families.
• Retirement benefits, including a 401(k).
• Paid holidays.
• Vacation.
• Compassionate and sick days.
• Eligibility for an annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree