Takeda
Biopharmaceutical
ManagerorStaff,APIManufacturingSciences(HikariPlant)/課長代理またはスタッフ,API技術グループ(光工場)
“Manager or Staff, API Manufacturing Sciences (Hikari Plant) / 課長代理またはスタッフ, API技術グループ (光工場) at Takeda. Skills: API Manufacturing, Process Chemistry, Data Science, Process Optimization. Plan and execute new product launches. Plan and execute process validation”
Industry & Context.
Troubleshooting; Process optimization
What They're Looking For.
Must Have
API or chemical organic synthesis and process chemistry scale-up experience, Data science (statistical analysis, multivariate analysis) or physical model (mechanistic model) process development/optimization experience, Process Analytical Technology (PAT) real-time process monitoring construction/operation experience, Basic understanding of chemical processes (reaction, separation, crystallization, drying), Knowledge of digital tools (Aspen, gPROMS, MODDE, CFD, SIMCA), Basic knowledge of statistical analysis (regression analysis, DoE, SPC) or multivariate analysis, English: reading, writing, and speaking for business operations
Nice to Have
Process chemistry or chemical engineering expertise, Hands-on experimental/investigation experience, Ability to tackle challenges diligently, Ability to challenge while discussing with diverse specialists
What You'll Do.
Plan and execute new product launches
Plan and execute process validation
Plan and execute technology transfer
Improve API manufacturing processes
Troubleshoot API manufacturing processes
Optimize processes using data science
Optimize processes using digital tools
Create GMP technical documents
Create and review regulatory submission documents
How You'll Work.
Team & Collaboration
Work with product team; Discuss with diverse specialists
Communication Scope
English communication
Process & Methodology
Planning, Execution
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