Senior Scientist, Small Molecule Chemical Engineering

MSD • Rahway, NJ

2d • Onsite

About The Position

The Senior Scientist, Engineering works in the Chemical Commercialization Technology (CCT) department within the manufacturing division, developing safe and robust manufacturing processes for late-stage small molecule pipeline projects. The role supports process characterization, technology transfer, validation, regulatory filing, and supply. It applies scientific and technical expertise, including Quality Risk Management methodologies and statistical design-of-experiments tools, in a collaborative setting with substantial technical responsibility and leadership of internal and external work.

The position includes hands-on experimentation at laboratory bench and kilo lab scales and technology transfer to commercial manufacturing facilities. The scientist is expected to prioritize safety and quality compliance, follow current Good Manufacturing Practices (cGMPs), and participate in risk assessments, deviation investigations, and Good Documentation Practices (GDPs).

Requirements

• Bachelor of Science (BS) or Master of Science (MS) in Chemical Engineering and at least five years of work experience, or a PhD in Chemical Engineering from an accredited college or university with no industry experience required.
• Relevant work experience in chemical process development.
• Demonstrated ability to develop and execute experimental programs addressing process design, robustness, and productivity.
• Highly effective communication and collaboration skills.
• Good organizational, interpersonal, writing, and time-management skills.
• Ability to work within a cross-functional process development team.

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 regulatory file authoring, validation planning, and execution.
• Experience guiding internal and external technical discussions.
• Familiarity with statistical design and analysis tools.
• Experience with process scale-up and technology transfer from laboratory to pilot plant or factory.
• Familiarity with cGMP concepts and application, ideally in pharmaceutical drug substance or drug product development and production.
• Experience with mathematical modeling, theoretical scaling calculations, and Quality by Design principles.

Responsibilities

• Develop safe and robust manufacturing processes through process characterization, technology transfer, validation, filing, and supply support for late-stage small molecule pipeline projects.
• Provide scientific expertise using Quality Risk Management methodologies and tools for statistical design of experiments.
• Conduct hands-on experimentation at laboratory bench and kilo lab scales.
• Transfer technology to commercial manufacturing facilities.
• Follow current Good Manufacturing Practices (cGMPs) and maintain a mindset of safety and quality compliance.
• Participate in risk assessments, deviation investigations, and Good Documentation Practices (GDPs).

Benefits

• Medical, dental, vision, healthcare, and other insurance benefits for employees and family
• Retirement benefits, including 401(k)
• Paid holidays
• Vacation
• Compassionate days
• Sick days
• Eligibility for annual bonus and long-term incentive, if applicable

What This Job Offers

• Job Type: Full-time
• Career Level: Senior