As a PAT Scientist, you will implement various inline/online techniques, instrumentations, and spectrometers to monitor and understand process insights of reaction conditions. Your role will involve building suitable predictive models for critical parameters such as concentration, crystallinity, reaction completion, and content/blend uniformity. Additionally, you will assist in the technology transfer to pilot plant and scale-up activities.
Key Responsibilities:
Investigate the feasibility of instruments for in-line monitoring of each assigned project step/unit operation.
Develop and refine predictive calibration models for real-time monitoring of component analysis during steps/reactions, adjusting these models as needed when process conditions change (e.g., solvent change, route change).
Analyze and report reaction trends from experiments utilizing in-line/on-line/at-line monitoring techniques, providing suggestions to control or modify process parameters/conditions.
Coordinate instrumentation across different projects to ensure optimal use of available tools based on project-specific needs.
Author or contribute to technical documents such as SOPs, technology transfer documents, process flow diagrams, regulatory submissions, patents, and scientific papers.
Support the development of automation systems (e.g., integrated control systems) between PAT tools and process data systems (e.g., syntQ or others) to maintain process control for critical process parameters (CPPs) and critical quality attributes (CQAs), facilitating real-time release testing from upstream to downstream processing units.
Required Qualifications:
PhD in Chemistry, Chemical Engineering, or a related field with a background in chemometrics/PAT and a strong focus on the application of vibrational spectroscopies (including but not limited to FTIR, Raman, particle size, NIR, etc.).
Demonstrated experience with PAT/statistical tools (e.g., Unscrambler, SIMCA, MATLAB/Eigenvector PLStoolbox, JMP), process modeling, and simulation principles (Dynochem) with the ability to solve complex datasets and problems.
Hands-on experience with iC software and instruments from Mettler Toledo (ReactIR, ReactRaman, Particle Track FBRM, etc.).
Understanding of safety protocols, Good Laboratory Practices (GLP), Good Documentation Practices (GDP), ICH guidelines, and USP requirements.
Preferred Qualifications:
Familiarity with Electronic Notebooks (ELN).
Excellent written and verbal communication skills.
Ability to work well in cross-functional teams.
Experience with Microsoft Office suite (Outlook, Teams, Word, Excel, PowerPoint).