Senior Scientist, Small Molecule Chemical Engineering
About The Position
The Senior Scientist works in the Chemical Commercialization Technology (CCT) department within the manufacturing division, applying scientific and technical expertise to develop safe, robust manufacturing processes for late-stage small molecule pipeline projects. The work supports process characterization, technology transfer, validation, regulatory filing, and supply. The role uses Quality Risk Management methodologies and statistical design of experiments. It includes hands-on experimentation at laboratory bench and kilo lab scales, as well as technology transfer to commercial manufacturing facilities. The scientist is expected to maintain a strong focus on safety and quality compliance, follow current Good Manufacturing Practices (cGMPs), and participate in risk assessments, deviation investigations, and Good Documentation Practices (GDPs). The position involves substantial technical responsibility and leadership of internal and external work in a collaborative environment.
Requirements
- Bachelor of Science (BS) or Master of Science (MS) in Chemical Engineering and a minimum of 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.
- 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 current Good Manufacturing Practices (cGMPs), 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 focus on 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
- Annual bonus eligibility
- Long-term incentive eligibility, if applicable
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What This Job Offers
Job Type
Full-time
Career Level
Senior
