Sr. Scientist, Engineering
Listed on 2026-01-14
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Engineering
Process Engineer, Biotechnology
Sr. Scientist, Engineering
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Job DescriptionThe 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).
Responsibilities- Develop safe and robust manufacturing processes through characterization, technology transfer, validation, filing and supply support of late‑stage projects.
- Perform hands‑on experimentation at laboratory bench and kilo‑lab scales.
- Apply Quality Risk Management methodologies and statistical design of experiments.
- Ensure adherence to Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDPs), and participate in risk assessments and deviation investigations.
- BS and/or MS with a minimum of 5 years relevant work experience or PhD in Chemical Engineering from an accredited college/university.
- Relevant experience in chemical process development, including developing and executing experimental programs to address process design, robustness and productivity issues.
- Highly effective communication and collaboration skills.
- Good organizational, interpersonal, writing, and time‑management skills.
- Ability to operate within a cross‑functional process development team.
- Experience performing lab‑based research/process development, including 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 from laboratory to pilot plant or factory.
- Familiarity with cGMPs ideally during pharmaceutical drug substance / product development and production.
- Experience with mathematical modeling, theoretical scaling calculations, and Quality by Design principles.
- Accountability
- Adaptability
- Bioreactors
- cGMP Regulations
- Chemical Engineering
- Chemical Manufacturing
- Chemical Technology
- Chromatographic Techniques
- Clinical Judgment
- Design of Experiments (DOE)
- Detail‑Oriented
- Deviation Investigations
- Good Manufacturing Practices (GMP)
- Innovation
- Machine Learning (ML)
- Manufacturing Processes
- Process Design
- Process Optimization
- Process Scale Up
- Quality Risk Assessment
- Risk Assessments
- Self Motivation
- Small Molecule Synthesis
- Strategic Planning
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
- EEOC Know Your Rights
- EEOC GINA Supplement
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