Associate Principal Scientist, Chemical Engineering R&D

Job Description

The Chemical Engineering Research & Development department (CERD), part of the Process Research and Development organization, is seeking a highly motivated and technically focused individual with chemical engineering experiences with applications in microbial fermentation operations and downstream bioprocess development to support manufacturing of enzymatic catalysts for small molecule drug substance applications.  Through direct, lab-based contributions and scientific supervision of a biochemical team, the Associate Principal Scientist collaborates with cross-functional teams to deliver manufacturing enzyme processes that meet target yield, activity, and purity to ensure clinical and commercial drug substance needs. This individual will play a critical role in enhancing internal technical capabilities by mentoring junior staff and advancing the functionalities of our fermentation and downstream processing in the laboratory, while also facilitating the transfer of technologies to commercial manufacturing settings. The successful candidate will employ data-rich experimentation and process modeling techniques to analyze experimental data, identify trends, and draw actionable insights that drive efficiency and yield improvements. Additionally, the candidate will utilize Quality Risk Management methodologies and statistical design of experiment tools to ensure robust manufacturing. The scientist is expected to maintain a strong focus on safety and quality compliance, which includes adhering to current Good Manufacturing Practices (cGMPs), participating in risk assessments, investigating deviations, and following Good Documentation Practices (GDPs).

A high level of innovation, creativity, and self-initiative along with the ability to plan and organize activities are expected.  Successful candidates will be required to communicate regularly, clearly, and effectively as they discuss technical problems, support benchtop and kilo-scale operations, and interface with cross-functional colleagues and stakeholders.

Required Experience and Skills:  

• For BS/MS candidates, at least 8 years of relevant work experience post-graduation - OR – for PhD candidates with at least 4 years of relevant work experience post PhD defense, where relevant work experience would include the following:

• Experience and knowledge in microbial fermentation and downstream process development and optimization.

• Demonstrations of performing lab-based research and process development with high throughput bioreactor systems, benchtop scale bioreactors, and/or production scale bioreactors.

• Experience with the design, optimization, and scale-up of product separation technologies common in protein manufacturing, such as centrifugation, flocculation, and/or filtration.

• Examples of process understanding, optimization, or scale-up using data-rich experimentation or model-based approaches. 

• Demonstrated capability to develop and execute an experimental program to address issues of process design, robustness, and productivity.

• Ability to mentor technical staff in the laboratory and through data analysis.

• Highly effective communication and collaboration skills.

• Good organizational, interpersonal, writing, and time management skills.

• Lead and operate within a cross-functional process development team.

Preferred Experience and Skills:

• Knowledge of concepts and application of ICH, cGMP and GDP during pharmaceutical drug substance development and production.

• Direct experience with pharmaceutical small molecule drug substance development with exposure to reaction, separations, and crystallization unit operations.

• Experience applying statistical experimental design (i.e. Design of Experiments) and analyses in chemical process development.

• Experience with risk assessments, process characterization, validation, and regulatory authoring.

• Proven track record of technical innovation and sharing of this work internally and externally via publications and conference presentations.

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