Research Position (CMC/Active Pharmaceutical Ingredient)

Our company, established through the business integration of Eisai and Ajinomoto, is one of Japan's largest specialty pharmaceuticals. You will be responsible for the process development of pharmaceuticals, enabling you to gain extensive experience from early development to commercial manufacturing. ◆ Process development for low molecular weight pharmaceuticals (from early development to commercial production) ◆ Preparation of reports on examination content and creation of patent specifications ◆ Technology transfer of developed processes to external contractors ◆ Liaison for clinical trial active pharmaceutical ingredients and commercial manufacturing at external contractors (including both low molecular and biopharmaceuticals) ◆ Liaison for obtaining laboratory data (including data for approval applications) at external contractors ◆ Preparation of Investigational Medicinal Product Dossier, IMPD, etc. ◆ Related tasks for new drug and some changes approval applications (CTD preparation / response to inquiries) ◆ Active Pharmaceutical Ingredient management for products being licensed in and out.

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The above information is a public job ad. This job ad is neither an offer nor a contract.