NEW 国内大手製薬メーカー Principal Scientist, Process Analytical Technologies, Analytical Development, Pharmaceutical Sciences

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勤務地	神奈川県藤沢市
仕事内容	How you will contribute: Independently design and execute diverse range of process analytical technologies to develop, optimize, monitor, model, and control pharmaceutical processes, with emphasis on continuous processing of drug substance and drug products. Expertise with inline spectroscopic methods (UV, IR, Raman) and chemometrics is required. Familiarity of regulatory requirements (ICH Q2/Q14) for analytical method qualification and validation are desired. Analytical control strategy/comparability knowledge of existing offline and online/inline methods to facilitate bridging away from the current standard. Expected to independently propose and implement resolutions to complex technical challenges. Responsible for significant or sole technical leadership within own program(s), provide technical guidance related to expertise across programs, delivering to organizational DDT (Digital Data and Technology) strategies. Serves as a technical resource within function, mentoring and training junior employees across multiple technologies. Reviews and interprets complex data, communicating clearly to functional leadership and relevant line functions. Leads technology transfer internally and externally, building key vendor relationships. Able to develop project strategy within AD and cross functionally and guide junior staff. Prepares documentation for regulatory filings, authors technical reports, may author publications. Able to work on multiple programs and represent AD within PS/project teams. Complete all required training appropriate to role and function in a timely manner.
経験・資格	※求人情報の応募要件全てに該当しなくても、企業様に対して内々に打診したり相談することが可能な場合もございます。一つでも当てはまる方は前向きにご検討下さい。 Minimum Requirements/Qualifications: Bachelors degree with relevant experience, Masters degree with relevant experience, Ph.D. with relevant experience Competent in multiple analytical techniques with advanced knowledge in specific analytical and real-time monitoring techniques relevant to analytical function, understands wider PS deliverables and project timelines. Able to communicate complex data clearly, able to work cross functionally, good scientific writing skills, able to work independently with minimal supervision, Good command of English language is required ※更なる詳細事項は、カウンセリング（面談）時にお伝えします。
企業データ	会社名 国内大手製薬メーカー 株式 上場 事業内容 医薬品の研究開発・製造・販売
Recruiting No.	02000762000807