Staff Engineer, Modeling

Role Summary

Staff Engineer – Process Modeling will join the Synthetic Molecule Process Development (SMPD) team to develop robust and cost-effective processes for the manufacture of new small molecule pharmaceuticals. The role focuses on chemical reaction engineering, modeling, scale-up/down studies, and the application of PAT and in-silico methodologies to design, optimize, and troubleshoot synthesis processes.

Responsibilities

• Contributes to the 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 across the global organization for in-silico process design, development, and optimization.
• Recommends, justifies and implements in silico tools and an "in-silico first” approach to process development
• Responsible for 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

• Required: Bachelor's degree in Chemical Engineering or related pharmaceutical science with 5+ years of relevant industry experience; Master’s degree with 3+ years; Ph.D. with 0+ years.
• Strong knowledge of chemical reaction engineering and catalysis, transport phenomena, and thermodynamics.
• Experience with reaction kinetic modeling software (e.g., ReactionLab, Dynochem, gPROMS, COMSOL).
• Experience with CFD software (e.g., Ansys, Star CCM+, MStar CFD).
• Proficient in communicating and collecting data from systems (sensors, controllers, industrial systems).
• Experience with Matlab, Python, R, SQL, and good coding practices.

• Preferred: Experience with statistical methods, basic data science and AI/ML methodologies; wet lab process development; multivariate analysis and PCA; understanding of synthetic molecule process development activities; understanding of cGMP.

Skills

• Analytical and problem-solving skills to troubleshoot critical issues and determine causes and solutions
• Teamwork and ability to work in a highly cross-functional, global environment
• Clear and concise communication, technical writing, and ability to adapt communication to the audience
• Time management, prioritization, and ability to manage multiple tasks
• Knowledge sharing to capture and propagate organizational knowledge
• Resource management for internal and external resources (vendors)
• External involvement through presentations at professional conferences or events
• Technical expertise in process modeling and simulation tools

Education

• Bachelor's degree in Chemical Engineering or related pharmaceutical science (5+ years) or Master’s/Ph.D. as alternative pathways with corresponding experience.