Staff Engineer, Modeling

Role Summary

Staff Engineer – Process Modeling in Synthetic Molecule Process Development (SMPD) to develop robust and cost-effective processes for small molecule pharmaceuticals, leveraging reaction kinetics, transport phenomena, mathematical modeling, and reactor design. Involves scale-up/scale-down modeling and applying PAT with mechanistic and statistical models to enhance process understanding and enable data-rich experimentation.

Responsibilities

• Contributes to design, development, optimization, and scale-up of manufacturing processes for synthetic molecule drug substances using process modeling and simulation principles.
• Utilizes advanced process modeling tools and digital twin functionalities, implementing model-based design of experiments for process characterization and risk assessment.
• Develops experimental designs and workflows for model development, validation, and verification.
• Collaborates with cross-functional and external partners to develop and deploy digital twins of unit operations.
• Partners with Automation, Manufacturing, Process Engineers, and PAT experts to develop modeling and simulation (M&S) solutions that can be deployed globally for in-silico process design, development, and optimization.
• Recommends, justifies and implements in silico tools and an "in-silico first‚Äù approach to process development.
• Authoring relevant sections of regulatory documents, validation plans, reports and peer-reviewed manuscripts.
• Proactively analyze technical issues and coordinate potential resolutions with project team members based on model and simulation predictions.

Qualifications

• Bachelor's degree in Chemical Engineering or related pharmaceutical science with 5+ years of relevant industry experience.
• Master's degree in Chemical Engineering or related pharmaceutical science with 3+ years of relevant industry experience.
• Ph.D. in Chemical Engineering or related pharmaceutical science with 0+ years of relevant industry experience.
• Strong knowledge of chemical reaction engineering and catalysis; transport phenomena and thermodynamics.
• Experience with ReactionLab, Dynochem, gPROMS, COMSOL; CFD tools such as Ansys, Star CCM+, MStar CFD.
• Proficient in data collection from sensors, controllers, and industrial systems; experience with Matlab, Python, R, SQL.

Preferred

• Experience with statistical methods, data science principles, and AI/ML methodologies.
• Wet lab process development experience.
• Multivariate analysis and PCA; understanding of cGMP.

Skills

• Analytical and problem-solving skills; ability to troubleshoot and determine root causes.
• Teamwork in cross-functional, global environments; effective communication and technical writing.
• Organization, time management, and ability to manage multiple tasks.
• Knowledge sharing and resource management; external involvement in professional community.
• Subject matter expertise in process modeling and simulation tools.