Senior Staff Engineer, Modeling and Data Applications

3316 Takeda Development Center Americas•Lexington, MA

9d•Onsite

About The Position

The Senior Staff Engineer, Modeling and Data Applications will be part of the Data & Modeling Applications Group within Biotherapeutics Process Development. This role will support process development and optimization of production processes for biopharmaceuticals through modeling approaches. The successful candidate will develop and optimize tools to enable development processes and model process economics for use in manufacturing facilities.

Requirements

Hands-on experience in process modeling applications (such as gProms, GoSilico, BioSolve, SIMCA, etc.)
Familiarity with cGMPs for biopharmaceuticals and regulatory submissions
Ability to work well independently as well as a member of a team
High communication skills
Excellent written and verbal communication
Programming skills (e.g. Matlab, Python)
Ability to present findings clearly to non-technical stakeholders
Ability to work in fast-paced environments
Teamwork skills for working in a diverse, global environment
Willingness to stay updated with the latest industry trends and technologies

Nice To Haves

Hands-on and lab-based process and/or high-throughput development experience is preferred.

Responsibilities

Mechanistic modeling of upstream and downstream processes with simulation software applications to enhance model-based process development
Modeling of process sustainability and economics of new or improved biopharmaceutical manufacturing platforms and fit into manufacturing facilities
Perform multivariate process trending analysis in support of development and optimization of manufacturing processes for biopharmaceuticals and bioconjugates
Model impact of innovative strategies on existing and new manufacturing processes
Apply modeling approaches to process development including model transfer learning
Provide modeling support for biopharmaceutical process characterization activities in preparation for process validation
Evaluation of process and cost modeling software applications for use in biopharmaceutical development
Collaboration with internal and external groups
Represent the Process Development Department on various project teams
Development of AI/ML model applications for hybrid models, and the exploration of innovative approaches to model building, including AI/ML techniques.