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部署・役職名 | Scientific Liaison for recombinant Flu |
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職種 | |
業種 | |
勤務地 | |
仕事内容 |
RESPONSIBILITIES Subject matter expert / technical expert for production of recombinant-based Flu family of vaccines, life-cycle improvements, and testing at s CMO in Japan. Recognized as a point of contact and technical contributor for troubleshooting non-conformance occurrences in manufacturing and supporting their on-time resolution. Develop and execute protocols for supporting tech transfer, scale-up, and process validation of processes to support project objectives ensuring adequate protocol scope, resource requirements, and objectives. Facilitate process monitoring, trend analysis, and investigations required for batch disposition, resolution of non-conformances and input to product life cycle. Must demonstrate the ability to critically analyze data from complex systems and recommend efficient courses of action for resolution. Propose opportunities for application of new technologies or process to existing platform to improve productivity, throughput, purity, quality, and/or compliance. Review and approve user requirements for manufacturing equipment. As a member of the CMO support team, effectively communicate status, risks, and opportunities to departmental or global partnership management and/or the project team. Provide technical support for regulatory submissions and reviews and maintain knowledge in technological advancements and regulatory trends applicable to the area of expertise. Work closely with other members of the department to share knowledge and competencies. |
労働条件 |
就労環境(抜粋) ・勤務地:委託先の岐阜工場 ・車通勤:可 ・勤務形態:週2在宅ワーク(フレックスタイム制度あり) ・試用期間:3か月 |
応募資格 |
【必須(MUST)】 • Bachelors or Masters in basic sciences, math, engineering, or pharmacy with 6+ years’ experience or PhD with 1+ years’ experience in biological processes or analytics in a cGMP environment. Candidate should possess educational and professional experience, commensurate with the position.• Expertise in Bioprocesses with knowledge of both drug substance and drug product operations • Excellent written and oral skills in Japanese and English • Expertise in large scale equipment setup, troubleshooting and maintenance • Has ability to work under very tight timelines while understanding the priority of the business and deliver results. • Strong interpersonal and communication skills: impactful oral and written communication. 【歓迎(WANT)】 • Preferred expertise in cell culture for protein production, application of single-use technology and Aseptic filling• Experience leading complex, multi-disciplinary troubleshooting efforts and data analysis |
アピールポイント | 自社サービス・製品あり 外資系企業 女性管理職実績あり 従業員数1000人以上 シェアトップクラス 年間休日120日以上 産休・育休取得実績あり 教育・研修制度充実 |
リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
受動喫煙対策 | 喫煙室設置 |
更新日 | 2024/03/26 |
求人番号 | 3401789 |
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