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新着求人 サプライチェーン  (LG-6)
募集職種 外資系製薬企業の Supply Analytical Scientist
その他の製薬(物流 ・購買)の求人はこちら
勤務地 東京または埼玉
会社概要 非公開
求人要件 【応募資格】
Ph.D. degree with 3+ years or BS/MS degree with 8+ years of pharmaceutical experience.
Author analytical procedures, methods development and validation protocols and reports, technical reports, experimental designs, regulatory submission documents, etc.
Perform investigations with strong technical troubleshooting skills and assist in developing/implementing CAPAs.
Provide documentation/technical input during inspections and audits (Regulatory and Internal) and have a working knowledge of data integrity and recent industry trends.
Have working knowledge of API and Drug Product development and commercialization and understand the needs related to commercial quality control.
Have working knowledge of developing various analytical techniques (e.g., chromatography, dissolution, spectroscopy) and product specification to support drug substance and drug product development and registration.
Have working knowledge of the process by which the products are brought to market.
Have experience working with CMO’s and CRO’s.
Have working knowledge of CMC filing requirements.
Demonstrate good verbal as well as written communication skills and ability to work in an interdisciplinary team environment.
Demonstrate interpersonal skills with flexibility and sensitivity in dealing with different cultures.
Self-motivated to take ownership and accountability of issues and drive them to completion.
Ability to speak up and raise issues and help to drive to resolution.
Ability to quickly adapt to changes and develop appropriate plans for managing risks.
Fluent in English and Japanese.
待遇 :850万から1500万程度想定(前職考慮)
このポジションは、SAS(Supply Analytical Support)という組織の中のAssociate Principal Scientistというポジションになります。今までは日本には置かれていなかったのですが、上記組織の中で各サイトにLiaisonを設置するという方針ができたようで、埼玉(東京でも可)でも採用することになりました。主に品質管理課で担当している品質試験の方法やプロセスの効率化、不具合が起こった時の対応、新製品導入時のKnowledge/Method Transferなどについて、分析的な視点からサポートを提供する、という役割です。APのDirectorに直接レポートすることになります。
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