Scientist, Analytical Research 3, Analytical Research Labs, Product Research & Development

Description 【募集の背景 / Purpose & Scope】 Product characterization, analytical method development and establishment of appropriate product control strategies aiming at IND/IMPD/BLA/MAA submissions and maintenance of commercial products for stable supply, for multiple biologics projects/products. In this position, it is required to independently carry out these tasks with minimal support from supervisors (team leaders or managers). 複数のバイオ医薬品のプロジェクト／製品において、IND/IMPD/BLA/MAA申請を目的とした製品特性評価、分析法の開発、適切な製品管理戦略の策定、および安定供給のための商業製品の維持を行います。本ポジションでは，上司（チームリーダーやマネージャー）の最低限のサポートで、これらの業務を独立して遂行することが求められます。 【職務の内容 / Essential Job Responsibilities】 （雇入れ直後） The person in this position has discretion in the performance of duties and achieves goals in the areas of test method development, commercial product maintenance, and certain functions including a certain amount of contribution to achieving the goals of the organization. Negotiate with related internal departments, manage related CMO/CRO, and nego...