Job Description

Summary

Step into a pivotal role where your expertise will drive the success of cutting-edge radioligand therapy (RLT) operations. As the MS&T Lead in Sasayama, you’ll lead technology transfer initiatives that shape the future of pharmaceutical manufacturing. Collaborating across functions—from Technical Development to Quality Control—you’ll ensure robust processes, seamless scale-ups, and regulatory readiness. This is your chance to make a meaningful impact in a high-growth environment while guiding a team toward excellence.
最先端の放射性リガンド療法（RLT）オペレーションを成功に導く、重要なポジションに挑戦しませんか？MS&Tリードとして、技術移管の取り組みを主導し、製薬製造の未来を形作る役割を担っていただきます。技術開発、品質管理、サプライチェーンなど多岐にわたる部門と連携しながら、スケールアップや規制対応を含むプロセスの強化を推進します。成長著しい環境の中で、チームを牽引しながら大きなインパクトを生み出すチャンスです

About the Role

Key Responsibilities

• Lead site-level technology transfer projects, ensuring timely execution and cross-functional alignment
• Deliver robust manufacturing processes that meet critical quality attributes and regulatory standards
• Implement analytical methods that comply with current Good Manufacturing Practices (cGMP)
• Ensure zero critical observations during internal and external GMP and Pre-Approval Inspections
• Manage project costs in line with approved Capital Approval Requests (CAR)
• Foster and embed Novartis’ company culture while building and developing a new team

Essential Requirements

• Minimum 8 years of experience in pharmaceutical manufacturing with strong expertise in pharmaceutical technology and project leadership
• Bachelor’s degree in Pharmacy, Pharmaceutical Technology, Chemistry, or related field; Master’s degree preferred
• Ability to shape a workplace culture that prioritizes cross-functional collaboration and overall optimization over siloed operations
• Hands-on mindset with a strong presence on the shop floor and willingness to lead by example

Desirable Requirements

• Experience with radioligand therapy (RLT) technologies or related manufacturing environments
• Proven ability to lead cross-functional teams in a regulated pharmaceutical setting

主な職務内容

• 技術移管プロジェクトを現場レベルで主導し、スケジュール通りに遂行
• 規制基準と品質属性を満たす堅牢な製造プロセスを構築
• cGMPに準拠した分析手法を導入・運用
• GMPおよび承認前査察において重大な指摘ゼロを達成
• 承認された資本支出（CAR）に基づき、プロジェクトコストを管理
• ノバルティスの企業文化を理解し、それを浸透させながら新しいチームを形成・育成

必須要件

• 製薬製造における8年以上の経験、製薬技術とプロジェクト管理の高度な知識
• 薬学、製薬技術、化学などの理系学士号（修士号尚可）
• 業務を縦割りせず、全体最適を優先する職場カルチャーの形成ができる方
• 現場を重視し、ハンズオンで積極的に行動できる方

歓迎要件

• 放射性リガンド療法（RLT）技術または関連製造環境での経験
• 規制環境下での部門横断型チームのリード経験

Benefits and Rewards:

You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

Commitment to Diversity and Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Accessibility and accommodation

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