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Job Function:
Supply Chain ManufacturingJob Sub Function:
Manufacturing Product & Packaging OperationsJob Category:
People LeaderAll Job Posting Locations:
Sunto, Shizuoka, JapanJob Description:
職務概要Position Summary:
- 安全、品質、信頼性、コストについての価値を提供する。
Deliver value for the site Safety, Quality Reliability and Cost.
- 富士工場での職務規則や作業標準を順守しながら、CAR-Tの調整、凍結保存プロセス作成、入出荷作業プロセスの作成及び作業をリード・管理する。また、チーム及びPeopleリードとして組織を管理する。
Lead and manage CAR-T operational coordination, the establishment of cryopreservation processes, and the development and execution of inbound and outbound shipment processes in compliance with Fuji Site work rules, SOPs, and work instructions. In addition, manage the organization as both a team leader and people leader.
- JJRC,外部GMP/CGTP査察等の対応および指摘事項に関する継続的な改善をチームの代表として積極的に行う。
Actively participate in the Kaizen activities regarding any observations from JJRC Audits, external audits, or GMP/CGTP inspections.
l部門・工場の目標達成に向けた管理、アクションプランや改善策を構築・実践する。
Manage, build and implement action plans and improvement to achieving critical metrics for departmental and site goals.
- JJPS /JJOSを主導・実践することで、富士工場のカルチャー醸成・リーン/6sigma推進を実施し、JJPSのストラクチャーを富士工場に根付かせるための変化を積極的に導く。
Lead the change in a positive way to build capabilities to support the site to apply the JJPS structure, to support JJPS/JJOS deployment and develop further Lean /6sigma methodologies.
l今後のCar-T Operation を効果的に運用するための人材の育成をリードする。
Support to build capabilities to effectively apply the JJPS principles and practices.
法規制の順守に関する責任 Regulatory Compliance Responsibilities:
- 品質と安全を最重要視する
Focus on quality and safety as top priority
- 法規制、GMP/CGTP、会社ポリシー、手順（SOP、WIなど）に留意しこれを遵守する
Align with regulation, GMP/CGTP, and all company/site policies/procedures
<応募要件>
教育/経験Education and Experiences:
- 大学・学士学位
University degree / Bachelor’s degree.
- People Management 経験
Experience in people management.
- 再生医療等製品実務の経験（ただし、GMP環境下での無菌操作やLabでの経験がある場合は必須ではない）
Practical experience with regenerative medical products; however, this is not mandatory if the candidate has experience in aseptic operations or laboratory
work in a GMP environment.
- 英語（基本的な業務上の会話が英語でできる 目安TOEIC650点以上）
English: Basic business communication skills, equivalent to a TOEIC score of 650 or above.
- 機器のQualificationまたはValidation経験があればなお良し
Experience in equipment qualification or validation is preferred.
- MBA、リーン、シックスシグマあればなお良し
MBA, Lean, or Six Sigma certification is preferred.
知識、資格、及び技能 Knowledge, Qualification and Skills:
- GMP/CGTP知識と現場経験
Familiar with knowlege of GMP/CGTPs and experience in a frontline position
- リーン、シックスシグマ知識・経験
Familiar with knowlege of Lean or Six Sigma and project experience for it.
行動特性Core Competencies:
- コラボレーションとチームワーク
Collaboration skills and teamwork-oriented mindset
- 柔軟思考と俊敏性
Flexible thinking and Agility
- 誠実なクレドバリュー
Credo value of integrity
- 顧客重視
Customer-focused mindset
- EHSルール及び手順の遵守
Always align with EHS rules and procedures.
その他 Others:
- 責任分野におけるオペレーションに精通する意欲があること
Have a mentality to try 100% knowledge and understanding in the operations of thier responsible area
- SAPおよびマイクロソフト各種アプリケーションを使用した業務に抵抗がないこと
Comfortable working in SAP environment and Microsoft Office tools
- ビジネス目標に対する改善、職場カルチャーの改善を、日々率先して行う姿勢
Need an approach and Behavior that are challenging the status quo to achieve business target
Required Skills:
Preferred Skills:
Agile Manufacturing, Analytical Reasoning, Brand Research, Coaching, Detail-Oriented, Developing Others, Good Manufacturing Practices (GMP), Inclusive Leadership, Leadership, Materials Handling, Organizational Knowledge, Package and Labeling Regulations, Package Equipment, Package Management, Plant Operations, Product Packaging Design, Quality Assurance (QA), Safety-Oriented, Work Order Management
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