Scientist CMC Development（物性研究所）

Description 【募集の背景 / Purpose & Scope】 Product characterization, analytical method development, analytical tech transfer and establishment of appropriate product control strategies aiming at IND / IMPD / CTD submissions and maintenance of commercial products for stable supply, for multiple projects / products. This position requires independent implementation of these activities with moderate support from team leaders and / or managers. 【職務の内容 / Essential Job Responsibilities】 （雇入れ直後） The person in this position achieves goals in the areas of test method development, tech transfer and commercial product maintenance to achieving the goals of the organization, under moderate extent of advice from supervisors. Negotiate with related internal departments, manage related CMO / CRO, and negotiate with external joint development partners for technical matters under the considerable support of supervisors. Perform the education and guidance to newly employed members according to the planning prepared by supervisors. Conduct the followings with moderate support from supervisors : Characterization of development products, development of test methods, planning of appropriate control strategies considering manufacturing processes / Preparation of application documents (IND / IMPD / CTD), support for other regulatory interactions, preparation of necessary documents / Analytical method transfer to testing sites / Improvement of work efficiency related to all of the above work / Training for new employees according to the planning. Some of the work related to laboratory operations. （変更の範囲） 会社内での全ての業務 【就業環境に関する要件 / Specific Physical or Environmental Requirements】 This position is based in Yaizu(AR2) and will require on-site work. Working in office and laboratory Working from home is also permitted where it will increase working productivity. 【応募要件 / Qualifications】 ＜必須 / Required＞ ・CMC analytical experience for drug substances and / or drug products. ・Those who have graduated from a master's degree (including 6th year of Pharmaceutical Science) or have equivalent knowledge.＜歓迎 / Preferred＞ ・Modality Knowledge Solid understanding of physicochemical and biological properties of synthetic small molecules, with the ability to directly influence product design.・Scientific Guidelines & Regulatory Intelligence Understanding of CMC-related ICH guidelines, and other relevant guidelines issued by major regulatory authorities (FDA, EMA, MHLW). ・CMC Analytical Knowledge Comprehensive understanding of testing items and analytical procedures required for establishing quality control strategy.・CMC Analytical Skills -Hands-on experience with major analytical instruments commonly used for characterizing / evaluating drug substances / products, especially HPLC. -More than 5 years of hands-on experience in analytical field.・Experiences -Analytical technology transfer to domestic and / or overseas CMOs / CROs. -Changes controls for commercial products from analytical perspective.・English Communication Skills -Experiences of oral communication of technical English for meetings and preparation(writing) of regulatory documents (e.g., IND, IMPD, CTD). -TOEIC >