Digital Drug Product Development Senior Research Associate

Job description

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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. Qualified applicants can apply at https://jobs.takeda.com . Please reference job #R0191461. EOE Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S.

Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue, NW, Room N-5311, Washington, DC 20210. Locations Lexington, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time