Senior Staff Engineer, Modeling

Role Summary

Senior Staff Engineer – Modeling within Synthetic Molecule Process Development (SMPD) at Takeda. Lead and develop scale-up/scale-down models using first-principle and data-based approaches, applying PAT and mathematical modeling to enable in-silico process design, development, and optimization. Report to Associate Engineering Fellow.

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 solutions that can be deployed globally 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 and 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 and 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.
• Maintain 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, identify process trends, and define/champion process strategy.
• Influence and support initiatives related to driving scientific and technical improvement within the function and 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 access technologies to deliver on pipeline and platform technology goals.
• Manage key vendor relationships across multiple projects and resolve issues arising at vendors.
• Represent Takeda and participate 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; experience with 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 data collection from sensors, controllers, and industrial systems.
• Experience with Matlab, Python, R, SQL, and good coding practices.

Preferred

• Experience with statistical methods, data science, 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; ability to troubleshoot and determine solutions.
• Teamwork and cross-functional collaboration across global functions.
• Strong communication and technical writing skills.
• Organization and time-management; ability to manage multiple tasks.
• Knowledge sharing and ability to contribute to organizational knowledge and models.
• Resource management including internal and external resources (vendors).
• External involvement evidenced by presenting at professional conferences.
• Technical expertise in process modeling and simulation tools.

Education

• As listed under Qualifications (degree requirements per level).

Additional Requirements

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