Digital Drug Product Development Senior Research Associate
Takeda
Summary
Takeda Development Center Americas, Inc. is seeking a Digital Drug Product Development Senior Research Associate to 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.
Job description
- 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.
Up to 10% domestic travel required for conference presentations, and site visits of CDMO and manufacturers. Up to 20% remote work allowed.
Requirements
- Master's degree in Biotechnology or related field OR Bachelor's degree in Biotechnology and 2 years of related experience
- Construct 3D geometric models using AutoCAD and SolidWorks
- 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
- Implement simulations, parameter estimation, and scenario analysis using Python and R
- 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 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
Benefits
- Medical, Dental & Vision
- 401(k)
- Paid time off
- Sick leave
- Company holidays
- Incentive compensation programs
Company overview
Takeda Pharmaceutical Company Limited is a Japanese multinational pharmaceutical company founded in 1781 and incorporated in 1925. As one of the world's top 20 largest pharmaceutical companies by revenue and the third largest in Asia, Takeda specializes in developing and commercializing innovative medicines across several therapeutic areas including oncology, rare diseases, neuroscience, gastroenterology, plasma-derived therapies, and vaccines. With approximately 49,095 employees globally, the company operates research and development centers, manufacturing facilities, and commercial operations across 39 U.S. states and numerous countries worldwide. Takeda maintains dual headquarters in Tokyo and Osaka, Japan, with significant operations in Cambridge, Massachusetts, where it serves as the largest life sciences employer in the state. The company's patient-focused approach is guided by its Takeda-ism values of Integrity, Fairness, Honesty, and Perseverance, emphasizing a commitment to delivering life-transforming treatments while advancing sustainable healthcare solutions. Takeda's extensive portfolio includes both innovative biologics and small molecule drugs, supported by strategic acquisitions and partnerships that have expanded its capabilities in areas such as immuno-oncology and rare disease treatments.