Senior Staff Engineer, Modeling

Role Summary

Senior Staff Engineer – Modeling at Takeda in the Synthetic Molecule Process Development (SMPD) group. Lead design, development, optimization, and scale-up of manufacturing processes for synthetic molecule drug substances using process modeling and simulation. Apply reaction kinetics, transport phenomena, mathematical modeling, and reactor design to develop in-silico process understanding, scale-up, and troubleshooting.

Responsibilities

• Lead and contribute to the design, development, optimization, and scale-up of manufacturing processes for synthetic molecule drug substances using process modeling and simulation principles.
• Utilize advanced process modeling tools and digital twin functionalities, implementing model-based design of experiments for process characterization and risk assessment.
• Lead and develop 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.
• Partner 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.
• Recommend, justify and implement in silico tools and an "in-silico first‚Äù approach to process development.
• Contribute to the democratization of modeling and simulation tools & results within global SMPD.
• Develop project or significant technical strategy and leverage technical skills as a resource/expert within the department.
• Recognized as a technical expert and resource within the function.
• Contribute significantly and independently to project work as well as the development of platforms, which may include multiple projects within the functional area.
• Proactively analyze technical issues and coordinate potential resolutions with project team members based on model and simulation predictions.
• Review, interpret and communicate data cross-functionally within pharmaceutical sciences and project teams.
• Significant technical responsibility for a project area/technical program within the department and potentially across Pharmaceutical sciences.
• Stay current in novel process modeling and simulation tools and platforms, identify process trends and define/champion process strategy.
• Influence and support initiatives related to driving scientific and technical improvement within the function and potentially cross-functionally.
• Identify topics for initiatives and lead local/global initiatives on behalf of senior staff.
• Author relevant sections of regulatory documents, validation plans, reports and peer-reviewed manuscripts.
• Identify vendors and build relationships to gain access to technologies as needed to deliver on pipeline and platform technology goals.
• Manage key vendor relationships across multiple projects as appropriate, and proactively address resolution of issues arising at vendors.
• Represent Takeda and participate as an active member in pre-competitive collaborations with academic and industrial partners.

Qualifications

• Bachelor's degree in Chemical Engineering or related pharmaceutical science with 11+ years of relevant industry experience.
• Master's degree in Chemical Engineering or related pharmaceutical science with 9+ years of relevant industry experience.
• Ph.D. or postdoctoral fellowship in Chemical Engineering or related pharmaceutical science with 3+ years of relevant industry experience.
• Strong knowledge of chemical reaction engineering and catalysis, with proven skills in these fields.
• Strong knowledge of transport phenomena and thermodynamics.
• Experience with reaction kinetic modeling software (e.g., Ansys, ReactionLab, Dynochem, gPROMS).
• Experience with CFD software (e.g., Ansys, Star CCM+, MStar CFD).
• Proficient in communicating and collecting data from sensors, controllers, and industrial systems.
• Experience with Matlab, Python, R, SQL, and good coding practices.

Preferred

• Experience with statistical methods, basic data science principles, and AI/ML methodologies.
• Hands-on experience in wet lab process development.
• Experience in multivariate analysis and PCA.
• Understanding of synthetic molecule process development activities and cGMP.

Skills

• Analytical and problem-solving skills
• Teamwork and cross-functional collaboration
• Strong communication and technical writing
• Time management and prioritization
• Knowledge sharing and organizational knowledge capture
• Resource management and vendor coordination
• External involvement through professional forums
• Technical proficiency in process modeling and simulation tools

Education

• As listed in Qualifications

Additional Requirements

• Travel: May require approximately 5-10% travel.