Senior Staff Engineer, Modeling

Role Summary

Senior Staff Engineer – Modeling within Synthetic Molecule Process Development (SMPD) at Takeda. Leads design, development, optimization, and scale-up of manufacturing processes for synthetic molecule drug substances using process modeling and simulation. Applies reaction engineering, transport phenomena, mathematical modeling, and reactor design to enable in-silico process development, optimization, 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 leverages technical skill(s) 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 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 defines/champions 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 affects resolution of issues arising at vendors.
• Represent Takeda and is an active member on 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; 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 statistics, 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 to troubleshoot issues and determine causes and solutions.
• Teamwork in cross-functional, global environments.
• Clear and concise communication; technical writing skills for internal documents.
• Strong organizational and time-management abilities; capable of managing multiple tasks.
• Knowledge sharing and ability to contribute to organizational knowledge and reusable models.
• Resource management including internal and external resources (vendors).
• External involvement through professional conferences or lectures.
• Subject matter expertise in process modeling and simulation tools.

Education

• As listed in Qualifications (degree requirements vary by level).

Additional Requirements

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