Senior Staff Engineer, Modeling

Role Summary

Senior Staff Engineer – Modeling at Takeda who will apply a strong background in chemical reaction engineering to tackle and lead challenging problems in chemical reactions. The role focuses on reaction kinetics, transport phenomena, mathematical modeling, and reactor design, with responsibilities for scale-up/scale-down models using first-principle and data-based approaches. You will apply process analytical technologies (PAT) and both statistical and first-principle models to enhance process understanding, enabling in-silico development, optimization, scale-up, and troubleshooting of processes. Reports to Associate Engineering Fellow within SMPD.

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” 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 affect resolution of issues arising at vendors.
• Represent Takeda and participate in pre-competitive collaborations with academic and industrial partners.

Qualifications

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

• Preferred: Experience with statistical methods, basic data science principles, and AI/ML methodologies.
• Preferred: Hands-on experience in wet lab process development.
• Preferred: Experience in multivariate analysis and Principal Component Analysis (PCA).
• Preferred: Understanding of synthetic molecule process development activities.
• Preferred: Understanding of current Good Manufacturing Practices (cGMP).

Skills

• Analytical and Problem Solving Skills – Able to troubleshoot critical issues or problems, and determine causes and possible solutions.
• Teamwork – Ability to work well in a highly cross-functional team environment and across global line functions.
• Communication Skills – Clear and concise written and verbal communication; ability to adjust communication style for the audience; strong technical writing skills.
• Organization – Strong time management and prioritization; ability to manage multiple tasks simultaneously.
• Knowledge Sharing – Ability to capture organizational knowledge and improve solutions, processes, and deliverables for others to use.
• Resource Management – Manage time and internal/external resources (vendors) within goals and timelines.
• External Involvement – Involvement in the professional community through conferences or events.
• Technical – Subject matter expertise in process modeling and simulation tools.

Education

• Bachelor's degree in Chemical Engineering or related pharmaceutical science (Required)
• Master's degree in Chemical Engineering or related field (Required)
• Ph.D. or postdoctoral fellowship in Chemical Engineering or related field (Required)

Additional Requirements

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