Senior Scientist, Small Molecule Chemical Engineering
About The Position
The Senior Scientist, Engineering position is part of the Chemical Commercialization Technology (CCT) department within the manufacturing division. The role uses scientific and technical experience to develop safe, robust manufacturing processes and supports late-stage small-molecule pipeline projects through process characterization, technology transfer, validation, filing, and supply support. It combines substantial technical responsibility with leadership of internal and external work in a collaborative environment. The scientist provides expertise in Quality Risk Management methodologies and statistical design of experiments, and conducts hands-on experimentation at laboratory bench and kilo-lab scales. The role also transfers technology to commercial manufacturing facilities. A strong focus on safety and quality compliance is required, including adherence to current Good Manufacturing Practices (cGMPs) and participation in risk assessments, deviation investigations, and Good Documentation Practices (GDPs).
Requirements
- Bachelor of Science or Master of Science 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 an experimental program addressing process design, robustness, and productivity issues.
- 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 with lab-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 their application during 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, 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
