Senior Staff Engineer, Modeling

Overview

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About the role

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Synthetic Molecule Process Development (SMPD) develops robust and cost-effective processes for the manufacture of new small molecule pharmaceuticals, along with methods for achieving and controlling high standards of purity and quality. The Senior Staff Engineer – Process Modeling will join a dynamic and innovative team of engineers and scientists within SMPD’s Process Engineering & Technology Group.

Join Takeda as a Senior Staff Engineer – Modeling where you will have a strong background in chemical reaction engineering and will tackle and lead challenging problems in chemical reactions by leveraging expertise in reaction kinetics, transport phenomena, mathematical modeling, and reactor design. You will also lead and develop the scale-up and scale-down models for studying unit operations using both first-principle and data-based models.

The role includes the application of process analytical technologies (PAT) combined with mathematical models (both statistical and first principle) to enhance process understanding. This will enable the effective development, optimization, scale-up, and troubleshooting of processes using in-silico approaches. As part of the SMPD, you will report to Associate Engineering Fellow.

How You Will Contribute

• 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 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 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…