Senior Scientist, Engineering

Senior Scientist, Engineering

The Chemical Commercialization Technology (CCT) department, which is part of our Manufacturing Division, is seeking a self-motivated individual who is looking for an opportunity to work in a highly collaborative environment that provides substantial technical responsibility and leadership of internal and external work.

The Senior Scientist, Engineering position leverages scientific/technical experience to develop safe and robust manufacturing processes through process characterization, technology transfer, validation, filing and supply support of late-stage projects in the small molecule pipeline.

The candidate will provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments. This role involves hands-on experimentation at the laboratory bench and kilo lab scales in addition to technology transfer to commercial manufacturing facilities. The scientist will be expected to exhibit a mindset of safety and quality compliance, which will include following current Good Manufacturing Practices (cGMPs), and participating in risk assessments, deviation investigations, and Good Documentation Practices (GDPs).

Position Qualifications:

Education Minimum Requirement:

• The position requires a BS and/or MS with a minimum of 5 years relevant work experience or PhD in Chemical Engineering from an accredited college/university.

Required Experience and Skills:

Relevant work experience in chemical process development, including the following:

• Demonstrated capability to develop and execute an experimental program to address issues of process design, robustness and productivity.
• Highly effective communication and collaboration skills.
• Good organizational, interpersonal, writing, and time management skills.
• Ability to operate within a cross-functional process development team.

Preferred Experience and Skills:

• Experience performing lab-based research/process development including performing unit operations common in small molecule drug substance process development such as chemical reactions, work-up, and crystallization.
• Experience leading regulatory file authoring, validation planning and execution.
• Experience guiding internal/external technical discussions.
• Familiarity with statistical design and analysis tools.
• Experience with process scale-up and technology transfer, moving from laboratory to pilot plant or factory.
• Familiarity with concepts and application of current Good Manufacturing Practices (cGMPs) ideally during pharmaceutical drug substance / drug product development and production, e.g. in a pilot and/or factory setting.
• Experience with mathematical modeling, theoretical scaling calculations, and Quality by Design principles.

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