[Innovative Medicine] Operations Staff , CAR-T Regional Supply Chain , Manufacturing and Supply Div.

About Johnson & Johnson

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.

Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at https://www.jnj.com/.

◇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の調整および凍結保存プロセス作成と作業をリ-ドする。

Aligning with the job rules and SOPs/WIs, lead to build process and operate for a formulation and apheresis cryopreservation.

• 必要に応じてCAR-Tの入出荷プロセスの作業を行う。

As required Car-T product in coming/release operation on each of Car-T drug products.

• 社内のレギュラトリ-•コンプライアンス部門や外部GMP/CGTP査察等からの指摘事項に関する継続的な改善をチ-ムの-員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.

• 社内の生産管理システムや,オペレ-ションシステム,Lean or Six sigmaを実践することで富士工場の改善カルチャ-醸成を積極的に導く。

Lead the change in a positive way to build capabilities to support the site to apply the Internal Production System structure, to support internal Production system and Operation System deployment and develop further Lean or Six sigma methodologies.

• 富士工場の品質管理または文化の向上のため,チ-ムの代表としてSubject matter expert (SME)業務を行う。それと同時に次世代のSMEやチ-ム運営のため,積極的に人材の育成に寄与する。
To improve the quality management and culture of the Fuji plant, represent the team as a Subject Matter Expert (SME).

At the same time, actively contribute to the development of the next generation of SMEs and team management.

• 製品導入までは,主に作業手順のブラッシュアップや,手順を学ぶ。

Until the product is installed, the main focus is on brushing up work procedures and learning procedures.

◇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 a top priority

• 法規制,GMP/CGTP,会社ポリシ-,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's policies and procedures•大学•学士またはそれに相当する学位ã...