Digital Drug Product Development Senior Research Associate

3316 Takeda Development Center Americas•Lexington, MA

3d•Hybrid

About The Position

Takeda Development Center Americas, Inc. is seeking a Digital Drug Product Development Senior Research Associate. This role involves developing robust drug product formulations and manufacturing processes, applying computational fluid dynamics (CFD) to understand and optimize unit operations, and utilizing digital twins for mechanistic understanding. The position also requires providing technical leadership, authoring protocols, designing experiments, generating reports, and contributing to CMC sections for regulatory submissions. Additionally, the role will lead and support in silico, simulation, and digital twin initiatives, integrating CFD models with experimental data, and applying modern computational approaches like machine learning and data analytics to pharmaceutical challenges. The associate will deliver applied data science, predictive modeling, and mechanistic process modeling support across multiple projects to enable robust process development, scale-up, and validation. Up to 10% domestic travel is required for conference presentations and site visits of CDMOs and manufacturers. Up to 20% remote work is allowed.

Requirements

Master’s degree in Biotechnology or related field OR Bachelor’s degree in Biotechnology and 2 years of related experience.
Prior experience must include: construct 3D geometric models using AutoCAD and SolidWorks and apply Computational Fluid Dynamics (CFD) using M Star CFD to simulate mixing studies, filtration studies, hydrodynamics, heat and mass transfer, transport phenomena, evaluate mixing time, mixing speed, power number, and scale effects in drug product manufacturing systems.
Develop mechanistic computational process models for mass, momentum, and energy balances and implement simulations, parameter estimation, and scenario analysis using Python and R to support biopharmaceutical process and product development understanding and risk assessment.
Design, execute, and support drug substance and drug product manufacturing processes, including technology transfer, equipment operation and troubleshooting, process validation studies, scale up and scale down model development, assay and media preparation, microbial biologics and monoclonal antibody production using perfusion and fed batch bioreactors.
Conduct site acceptance testing for equipment for lab equipment.
Programming recipes into Delta V as a Delta V superuser & measure tanks, bags and process developed using multiple scales (Scale up and scale down) in pilot & manufacturing scale.

Responsibilities

Develop robust drug product formulations across the product lifecycle, including development and tech transfer of scalable, robust drug product manufacturing processes from early phase through process validation.
Apply computational fluid dynamics (CFD) with a strong focus on mixing and filtration operations to understand, design, and optimize drug product unit operations.
Utilize CFD principles and tools (including M-Star CFD) to build and deploy digital twins of drug product development processes, enabling mechanistic understanding of mixing, suspension uniformity, shear exposure, filtration performance, and scale-up risk.
Provide technical leadership and guidance for formulation and drug product development.
Author technical protocols, design and execute experiments, generate technical reports, and contribute to CMC sections supporting regulatory submissions.
Lead and support in silico, simulation, and digital twin initiatives, integrating CFD-based mixing and filtration models with experimental data.
Apply modern computational approaches including machine learning, data analytics, statistical and chemometric methods—to traditional pharmaceutical formulation and process development challenges.
Deliver applied data science, predictive modeling, and mechanistic process modeling support across multiple projects to enable robust process development, scale-up, and validation.