Digital Drug Product Development Senior Research Associate

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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 methodsto 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 applicants qualifications experience skills education certifications & work location & will comply with all applicable minimumwage 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: Masters degree in Biotechnology or related field OR Bachelors 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. $100755 to $141240 per year.

Qualified applicants can apply at . 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.

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Senior IC