Digital Drug Product Development Senior Research Associate

USA - 3316 Takeda Development Center Americas, Inc.; Lexington (MA); Hybrid; USD 101,000 - 141,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k)

Paid time off

Sick leave

Holidays

Job summary

Takeda Development Center Americas, Inc. in Lexington, MA is seeking a Digital Drug Product Development Senior Research Associate to develop robust drug product formulations across the lifecycle and drive tech transfer of scalable manufacturing processes from early phase through validation.

The role applies CFD (including M-Star CFD) to optimize mixing and filtration, builds digital twins, and leads data analytics, machine learning, and mechanistic modeling to enable robust process development

Qualifications

• Master’s degree in Biotechnology or related field, or Bachelor’s degree in Biotechnology with 2 years of related experience.
• Experience with AutoCAD, SolidWorks, and CFD using M Star CFD to simulate mixing and filtration studies, hydrodynamics, and scale effects.
• Experience designing, executing, and supporting drug substance/product manufacturing including tech transfer, process validation, and scale-up.
• Experience with Python and R for parameter estimation, simulations, and risk assessment in biopharmaceutical development.

Responsibilities

• Develop robust drug product formulations across the lifecycle and transfer to manufacturing.
• Provide leadership and guidance for formulation and product development; author protocols and reports.
• Lead in silico, simulation, and digital twin initiatives; deploy CFD-based models with experimental data.
• Apply data analytics and machine learning to support robust process development and regulatory submissions.

Skills

AutoCAD

SolidWorks

CFD

Python

R

Machine learning

Data analytics

Experiment design

Education

Master’s degree in Biotechnology or related field

Bachelor’s degree in Biotechnology with 2 years related experience

Tools

M Star CFD

DeltaV

Job description

Job Description Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Takeda Development Center Americas, Inc. for the following job opportunity:

JOB LOCATION: Lexington, MA

POSITION: Digital Drug Product Development Senior Research Associate

POSITION DESCRIPTION: Takeda Development Center Americas, Inc. is seeking a Digital Drug Product Development Senior Research Associate with the following duties: 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.

Up to 10% domestic travel required for conference presentations, and site visits of CDMO and manufacturers. Up to 20% remote work allowed. Estimated salary range reflects expected pay for this role. Actual base salary depends on the applicant’s qualifications, experience, skills, education, certifications, & work location, & will comply with all applicable minimum‑wage laws.

U.S. employees may be eligible for medical, dental, & vision insurance, 401(k), paid time off, sick leave, company holidays, incentive compensation programs, & other benefits offered under company policies.

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. Full time. $100,755 to $141,240 per year.

Locations Lexington, MA

Worker Type Employee Worker Sub-Type Regular Time Type Full time

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer.

EOE