Senior Scientist, Engineering

Merck • 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. The position has a particular focus on microbial fermentation and downstream processing for enzyme manufacturing, optimizing and characterizing process control strategies across different scales.

The successful candidate will help build internal technical capabilities by mentoring junior staff and enhancing fermentation and downstream-processing laboratory capabilities. The role also supports technology transfers to commercial manufacturing and involves hands-on experimentation at laboratory bench and kilo-lab scales. The scientist is expected to follow safety and quality requirements, including current Good Manufacturing Practices (cGMPs), and participate in risk assessments, deviation investigations, and Good Documentation Practices (GDPs).

Requirements

• PhD in Chemical Engineering, Bioprocess Engineering, Biological Engineering, Synthetic Biology, or a related field from an accredited college or university.
• 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 an experimental program 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 the laboratory and through data analysis.
• Highly effective communication and collaboration skills.
• Good organizational, interpersonal, writing, and time-management skills.
• Ability to lead and operate within a cross-functional process development team.

Nice To Haves

• Experience performing laboratory-based research or process development, including small-molecule drug-substance unit operations such as chemical reactions, work-up, and crystallization.
• Experience leading file authoring, validation planning, and execution.
• Experience guiding internal and external technical discussions.
• Familiarity with statistical design and analysis tools.
• Familiarity with cGMP concepts and applications, 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 fully characterize enzyme manufacturing process control strategies across different scales, using expertise in microbial fermentation and downstream processing.
• 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 experiments at laboratory bench and kilo-lab scales.
• Ensure safety and quality compliance, including adherence to cGMPs and participation in risk assessments, deviation investigations, and GDPs.

Benefits

• Medical, dental, vision, healthcare, and other insurance benefits for employees and family.
• Retirement benefits, including 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