武田薬品工業株式会社のStaff, Solution Hub, TBS Procurement Solutions Japan / TBS プロキュアメントソリューションズ ソリューションズハブ（一般社員）求人

Please note this job requires native-level Japanese language command not only in speaking, business writing and reading, as well as strong English communication skills to collaborate effectively and lead discussions in a global organization.

タケダの紹介
タケダでは常に患者さんを中心に考え、世界中の人々により健やかで輝かしい未来をお届けすることを目指してきました。そして従業員一人ひとりにそれぞれの能力と熱意に応じた成長の機会を提供することにも取り組んでいます。私たちと一緒に、世界中の人々のいのちに貢献し、さらなる成長と活躍を目指しませんか。

タケダは業界を牽引するグローバルリーダーです。従業員は四つの優先順位（患者さん中心、社会との信頼関係構築、レピュテーションの向上、事業の発展）とタケダイズム（誠実＝公正・正直・不屈）のもと一致団結しています。タケダイズムは私たちの信念であり正しい方向へ導く羅針盤です。私たちは日々の業務においてタケダイズムを体現しています。

職務内容
Provide technical leadership and subject matter expertise for the Early In-Process Analytics function by contributing to strategy, standards, and testing plans for early-stage process development and GMP sample testing.
Serve as a subject matter expert in analytical methods used for protein-based large-molecule in-process testing.
Manage method transfer and implementation from Analytical Development, including Biologics AD & QC, for platform methods and molecule-specific assays.
Execute method qualification, verification, and validation activities to meet regulatory and quality requirements for GMP testing.
Collaborate closely with Global IPA to align methods, data formats, reporting, and operational workflows across regions.
Design and execute analytical experiments and test plans to support process characterization, troubleshooting, and scale-up decisions.
Ensure data integrity, maintain sample chain-of-custody, and prepare technical reports and documentation to support development and regulatory submissions.
Provide technical guidance to laboratory members, support training on new assays, and maintain clear communication with development and manufacturing partners.
Work with automation and digitalization colleagues to support commissioning and qualification of laboratory and process analytics equipment, automation, and data systems.
Drive continuous improvement in IPA workflows, sample handling, turnaround time, and documentation practices while balancing quality and compliance.

応募要件
＜学歴＞
Bachelor’s degree in Chemistry, Engineering, Biology, Analytical Chemistry, or related Pharmaceutical Science and 7+ years relevant industry experience.
Master’s degree in Chemistry, Engineering, Biology, Analytical Chemistry, or related Pharmaceutical Science and 5+ years relevant industry experience.
PhD in Chemistry, Engineering, Biology, Analytical Chemistry, or related Pharmaceutical Science and 3+ years relevant industry experience.

＜実務経験＞
Extensive experience in CMC analytical development for drug substance molecules and processes.
Developed expertise in multiple areas of analytical technology and demonstrated in-depth working knowledge of program strategy, including experience with early-stage assets.
Knowledge of analytical techniques with advanced experience in multiple techniques for large-molecule processing.
Experience with method development, phase-appropriate validation, ICH expectations, and method transfer; ability to design and direct analytical strategy to meet CMC project objectives.
Experience in writing regulatory documents with sound knowledge of current cGMP.
Proven external scientific track record through presentations at scientific conferences and publication of peer-reviewed manuscripts is preferred.

＜スキル・資格＞
Good attitude toward continuous learning and adaptability to evolving scientific domains and global development practices.
Ability to analyze a wide variety of information and data, including statistics, data sciences, and in silico modeling, to support decisions regarding potential risks associated with product quality and regulatory compliance.
Ability to quickly abstract key insights and apply them to new or unfamiliar contexts.
Excellent organizational and communication skills, including the ability to influence at all levels of the organization and manage projects across businesses and regions while adapting effectively to different cultural and organizational contexts.

＜語学＞
Native-level Japanese proficiency in speaking, business writing, and reading.
Strong verbal and written communication skills in English.
Ability to participate in and lead technical discussions, presentations, meetings, and scientific/business documentation in English within a global environment.
Ability to collaborate effectively with Global IPA and cross-functional partners across regions.

＜その他＞
求める人物像
A scientific leader who demonstrates Takeda-ism and keeps patients at the center of decision-making.
A technical expert who can work effectively in a global and cross-functional environment.
A proactive contributor who is motivated to help build a new analytical function and improve analytical platforms, workflows, and people capabilities.
A collaborative professional who values technical excellence, practical execution, and data-driven development and manufacturing decisions.