求人情報一覧

職務内容 ・製造および試験設備の導入に関連する文書レビュー ・技術移管関連の文書レビュー ・バリデーション関連の文書レビュー（バリデーションマスタープラン、プロセスバリデーションなど） ・GMP製造のための文書レビュー（マスターバッチレコード、試験法など） ・製造時の品質保証業務（現場監視、実施済のバッチレコードレビューなど） ・ワクチンの出荷に関連する業務 当局査察の対応 ※ご経験やキャリア志向を勘案して、上記の中から担当業務を幾つか選択させていただきます。

【主な業務内容】 • 社内ソフトウェアアプリケーションのサポート • 以下の技術専門分野における小規模ソリューションプロジェクトの技術標準分析、実装、評価に参加および実行 — エンドユーザーサポート — ハードウェアのトラブルシューティングと故障対応 — オペレーティングシステム・ソフトウェアのサポート — ハードウェア・ソフトウェアツールとITILプロセスに沿った運用 【詳細な業務内容】 • 問題の調査、解決策の分析、小規模なプロジェクトの技術的な変更の実装など • 要件、整備、テスト、問題、アプリケーション統合などの分析 • ガイドラインやポリシーに沿った意思決定のサポート、またはチームメンバーに対してのサポートに関する意思決定の支援 • 技術的な分析・設計・変更・ソフトウェア設定・ハードウェアの解決支援を武田薬品の標準に沿って実行 • 通常業務内やプロジェクト内でのアプリケーションの開発サービスやテクニカルサポートの提供 • ビジネスソリューションの本番環境への展開サポート、エンドユーザー機器のライフサイクルプロセスとIT資産管理 • 社内ITインフラストラクチャとエンドユーザー機器の対面式サポートの実施 • 会議室や会議イベントのサポート • システム改善策の実装支援 • 武田薬品の品質マネジメントシステム(QMS)、ソフトウェア開発ライフサイクル(SDLC)、およびITプロジェクトライフサイクル(ITPLC)の標準、ポリシー、および手順に従ったサポートドキュメントの作成・維持 • マネージャ・リーダーからの指導と指示の下での業務遂行 • 主要なITおよびビジネスの目的/目標を理解し、自己知識を独自の作業分野で活用 【関連業務】 • 計画された取り組みに対する定期的な更新と、テクノロジー運用とプロジェクトに関するレポートの提供 • 管理業務のデータ精度を確保

【職務内容】 光工場における製品出品計画を達成するため、原材料・製品に関する微生物学的な試験の実施、試験引継ぎ、SOP・記録書の作成および安定性調査・バリデーションなどに関する試験を行う GMP要件に基づく試験（原材料・製品の微生物学的試験） 査察や監査時の対応 試験に関する技術・技能継承 公定書、申請書の試験に関連する業務 作業改善・効率化に関する業務 最新技術（迅速微生物技術等）の導入に関する業務 チームリード： 生産計画と出荷計画に基づいて試験計画を作成・実行 無菌試験 エンドトキシン試験 微生物限度試験 マイコプラズマ否定試験 培地充填試験 微生物同定試験 環境調査、工程使用水の微生物学的試験 試験業務に関連する専門知識を共有してチームメンバーの能力向上を推進

職務内容 生物学的製剤における培養、精製工程作業およびそれに伴う以下のような周辺関連業務 製造工程や設備のバリデーション／クオリフィケーション ワクチン製造に関わるドキュメントの作成 当局の査察の対応 生産トラブルの対応

ACCOUNTABILITIES Manage, identify, hire, and develop a team to support commissioning and qualification of a new Plasma Manufac-turing facility. Manage continued growth, development, and retention of the team. Applies thorough understanding of risk-based CQ, cGXPs, GAMP5 and 21CFR Part 11 (as applicable), relevant SOP curriculum, routine project procedures, and other training as appropriate. Responsible for planning, scheduling, and leading commissioning and qualification assignments. Must demon-strate competent and effective planning, coordination, and organizational skills. Lead and interface with cross-functional team members (Engineering, Manufacturing, Regulatory Affairs, Quality, Supply Chain, and other technical disciplines) representing the respective commissioning and qualification ele-ments, as applicable, to develop the commissioning and qualification strategy based on concepts of risk-based CQ which includes user requirements, functional specifications, design specifications, commissioning and qualifica-tion. Emphasis is on ensuring commissioning and qualification activities meet defined timelines and budget while being in compliance with regulatory guidelines and industry standards. Guide peers in Commissioning and Qualification and Engineering Departments to use sound, statistically based Quality Engineering approaches in project, test plans and in analyses and interpretation of test results. Review documentation for accuracy and compliance to established procedures with the ability to approve or reject as appropriate. Ability to present a course of action to management and project team using both written and verbal communication tools. Assist with regulatory agency inspections, including interfacing with inspectors and corporate/division/internal auditors. Present commissioning and qualification strategy and protocols in regulatory inspections. Supervise commissioning and qualification personnel, contractors and outside vendors to meet project timelines, goals and milestones. Monitor and report commissioning and qualification costs including capital and cross-functional expenses. Perform other duties as directed by supervisor. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Must have vast experience, proficiency and leadership in pharmaceutical/biotech commissioning and qualification of large capital projects. which includes the writing and executing of protocols and standard operating proce-dures. Strong knowledge of GMPs, FDA and EU guidelines/requirements, is required. Must be considered a proficient Subject Matter Expert (SME) in all commissioning and qualification elements. Leadership Must have exceptional organizational skills and ability to analyze and plan and implement resolutions to technical problems, familiarity with auditing techniques, interpreting regulations and quality systems. Leadership and project management skills such as exceptional interpersonal/communication/influencing/negotiation skills/organization/prioritization. Decision-making and Autonomy Must demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team management. Interaction Must be able to work with site and global SMEs from External Partners, Engineering, Manufacturing, Quality, Regulatory and EHS in order to meet timelines, budgets and desired outcomes. Innovation Must be able to lead and implement optimization of processes within the department or the site. Complexity Must have advanced experience and proficiency in problem analysis and resolution, successful track record of analyzing complex technical problems, and demonstrates good troubleshooting and decision-making abilities.

OBJECTIVES/PURPOSE This position will provide support to the execution of commissioning and qualification of a new Plasma manufacturing facility. This position is responsible to assess and qualify equipment, critical systems (utilities), facilities, computer systems, cleaning processes, manufacturing processes, as applicable. Primary tasks include development of protocols, coordination of commissioning and qualification activities, qualification execution, preparing final reports and assembly of final commissioning and qualification packages, and generation of project plans. Responsibilities will consist of both initial commissioning and qualification efforts as well as re-commissioning and re-qualification. Additionally, investigations of manufacturing challenges are conducted and process improvements are evaluated and implemented. Final documents are archived and will be included in or support regulatory submissions, and made available as needed during internal and external regulatory/compliance audits. This position will work in close cooperation with the manufacturing business units, Engineering, Regulatory, QC, and Quality Operations on a day-to-day basis. ACCOUNTABILITIES Applies thorough understanding of risk-based CQ, cGXPs, GAMP5 and 21CFR Part 11 (as applicable), relevant SOP curriculums, routine project procedures, project management, and other training as appropriate. Performs a variety of projects/studies in several areas at the same time to support project timelines and budgets while maintaining quality and compliance. Supports projects that require team participation. Must demonstrate competent and effective coordination, and organizational skills. Handles routine tasks with attention to detail, timely and accurately. Participates and interfaces with cross-functional project team members (Engineering, Manufacturing, Regulatory Affairs, Quality, Supply Chain, and other technical disciplines) representing the respective commissioning and qualification elements, as applicable, to determine commissioning and qualification strategy based on concepts of life cycle: user requirements, functional specifications, design specifications, commissioning and qualification. Emphasis is on ensuring accuracy and integrity on commissioning and qualification documentation that meets regulatory guidelines and industry standards. Writes protocols and reports, executes, interprets, and evaluates commissioning and qualification documents in terms of acceptability to industry standards (GMPs, FDA Guidelines), procedures, and regulatory requirements such as but not limited to (21 CFR Parts 210, 211, 600, ISO 14644, EC-Annex1, etc.). Utilizes Quality-Engineering tools to problem solve/troubleshoot and assist in risk analysis (e.g., FMEA, Design of Experiments, QbD, SPC). Identifies gaps related to commissioning and qualification requirements and global procedures. May assist in closing compliance gaps as they are identified. Performs updates to element commissioning and qualification assessments and commissioning and qualification plans, as required. Participates, as required, in the investigation and closure of non-conformances/events, corrective actions and preventative actions. Supports internal or external assessments or audits, as required. Supports process with timely closure of observations/audit items. Uses commissioning and qualification test equipment in support of commissioning and qualification activities. Performs other duties as directed by supervisor. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Must have basic experience in pharmaceutical/biotech commissioning and qualification elements, as applicable, including the writing and executing of protocols and standard operating procedures. Must have basic knowledge of the operating principles in a cGMP regulated environment. Hands-on Manufacturing, Engineering and/or Technical Service experience is a plus. Leadership Must have exceptional organizational skills and ability to analyze and plan and implement resolutions to technical problems, familiarity with auditing techniques, interpreting regulations and quality systems. Leadership and project management skills such as exceptional interpersonal/communication/influencing/negotiation skills/organization/prioritization. Decision-making and Autonomy Must demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, and problem solving Interaction Must be able to work with site and global SMEs from External Partners, Engineering, Manufacturing, Quality, Regulatory and EHS in order to design, execute and deliver to department goals and project goals. Innovation Must be able to lead and implement optimization of processes within the department or the site. Complexity Must have advanced experience and proficiency in problem analysis and resolution, a successful track record of analyzing complex technical problems, and demonstrates good troubleshooting and decision-making abilities.

About the role: Manager, Japan IP will develop and provide IP strategy and direction in the assigned projects / tasks, especially relating to DD&T field in or across Therapeutic Areas, in Japan IP. You will contribute to global TA support activities, especially relating to DD&T, as part of Global IP TA or Product team on the matters delegated by the team leader (Director, Japan IP). You will serve as a strategic advisor in DD&T related projects within and beyond IP department, and while acting as a primary point person for IP-related matters in DD&T field for select internal communication channels, provide valuable support to enhance DD&T capabilities of Japan IP. How you will contribute: In consultation with the supervisor, develop and implement IP strategies by itself based on region and local needs, including exploring any Business Development (BD) opportunities on the matters delegated by its supervisor, involving relevant stakeholders. As a member of the team, contribute to develop and conduct operational excellences at Japan IP. As a member of the team, contribute to develop and implement short-term and mid-to-long term goal of the team, which covers both activities and budgets Develop human network and find key stakeholders outside IP such as the counterparts at R&D and Commercial functions Develop solutions and resolve problems in the scope of the assigned responsibility, where relevant legal precedents in the area of IP may not exist and laws or regulations are ambiguous Support global IP activities such as TA activities, litigations and business development in the scope of the assigned responsibility Understand the Company’s current and planned business activities, products, facilities, customers, competitors, markets and functions in order to identify relevant legal trends, laws and regulations relating to the assigned tasks. Support and contribute to the external affairs in the regional IP industry groups and attorney associations in Japan Effectively work with outside counsel providing additional legal services relating to IP, and monitoring and controlling fees and expenses in the scope of the assigned tasks.

職務内容 主力生産工場である光工場にて、低分子医薬品、高活性医薬品の製造に関する下記業務を担当いただき、早期上市、安定供給および生産性向上に貢献いただきます。 ・新製品の工業化に向けた化学合成プロセス検討 ・国内外の製造委託先への技術移管及び技術指導 ・光工場における原薬製造のプロセス改良およびトラブル解決 ・国内外での薬事申請・照会対応、ならびに当局・販社の査察対応 ・原薬製造プロセスへの新規技術の適用

OBJECTIVES/PURPOSE: Takeda creates sustained growth through values-based impact. We operationalize our corporate philosophy to create long-term value with our corporate values. By using our core strengths and capabilities as a biopharmaceutical company, Takeda creates long-term value for patients, shareholders and society while also sustaining positive impact for our people, communities, and the planet. Our sustained growth through enduring values fuses why we exist (our purpose) with where we are going (our vision) and how we deliver on our vision (our values). Our Leadership Behaviors, anchored in our values, guide our employees on how to deliver operations consistent with our vision and purpose. We believe that everyone in Takeda is a leader regardless of their role and we expect our people to focus on four behaviors: Think Strategically, Inspire Others, Deliver Priorities and Elevate Capabilities as they contribute to our vision and purpose. Our imperatives and priorities direct where Takeda must focus to deliver on our vision and purpose. Informed by a materiality assessment, these imperatives and priorities are framed under patient-people-planet powered by data, digital and technology with corporate philosophy metrics that hold us accountable for making progress on these focus areas. With that in mind, this role will help further Takeda’s sustained growth to: • Establish internal control systems of ESG data to protect corporate reputation • Empower people in this organization who create and perform long-term value creation to build, promote and protect corporate reputation ACCOUNTABILITIES: 1. Be a leader and empower team and people building knowledge around sustainability and ESG, and what it will take for sustainability as an enabler for us to bring long-term value creation to life. 2. Demonstrate the leadership as a member of the Sustainability LT with Head of Global Sustainability and Head of Sustainability Network Management based out of Boston reporting directly to Head of Global Sustainability and co-own the team performance and capability building, drive team culture and embrace life-long learning mindset. 3. Be accountable for internal control system of ESG data by partnering with responsible corporate functions based in Tokyo and Boston, which meet forthcoming requirements (e.g. Annual Integrated Report, ESG indices, and non-financial metrics in financial reportings) and leverage existing operating models 4. Drive ownership/leadership of internal stakeholders to shape conversations of sustainability/ESG to activate build sustainability ambassadors foundation (e.g. voluntary employee engagement group) to promote corporate reputation 5. Supervise outside stakeholders’s engagement and work collaboratively with Boston-based team members to build trust with prioritized outside stakeholders given the variety of outside stakeholders (e.g. institutional stakeholders, shareholders, financial advisory, pharma/non-pharma organizations, regulatory) . 6. Provide outside-in data-driven ESG insights that can be great impact for innovation and sustainability stories to strengthen favorability and familiarity of Takeda 7. Partner with senor leaders (TET-1 and -2) to clarify our message towards sustainability through leadership communication to set up their aspiration in the future CORE ELEMENTS RELATED TO THIS ROLE: • Inclusive leadership for people 1. Effective collaboration: Empower others, pay attention to diversity of thinking and psychological safety, and focus on team cohesion 2. Curiosity about others/Inspire others/think about others: Demonstrate an open mindset and deep curiosity about others, listen without judgment, and demonstrate empathy to understand those around 3. Humility: Be modest about capabilities of self and others, accept mistakes and encourage to learn, and create the space for others to contribute. 4. Cultural intelligence: Be attentive to others’ cultures and adjust style as required for effective teamwork given taking a global role with partnering so many stakeholders with different back-grounds and cultures • Values-based governance/decision-making for the organization 1. Commit to process-driven and transparent governance and operating model 2. Enhance agile decision-making to fit for purpose by having conitinued and trusted partnership with key stakeholders fully engaged 3. Strong problem solving skills : critical thinking, process information, creativity that allows to break down difficulties and challenges into smaller, easier and getting ahead to more mana-geable points • Flexibility and resilience mindset for sustainability and ESG 1. Fully capable of understanding the enterprise agenda and its requirements, which is still evol-ving given uncertain ESG world outside. Need capability to catch outside ESG perspective and bring right key takekaways to Takeda sustainability strategy 2. Be flexible to review and adjust priorities in line with our sustainability/ESG agenda and capable to orchestrate all the components that can help leaders decide right directions towards Takeda’s long-term value-creation 3. Thrive in ambiguity and ongoing operations towards getting directions : linked with #1, need to think about the optimal approach given current situation and information that leaders are having by being mindful of our organizational vision and purpose with enduring values and being aspira-tional to aim stretching areas we are capable to explore.

募集部門の紹介 タケダの国内最大工場で、医薬品原薬・医薬品を製造しています。その品質管理を行う部門で原料の受け入れから出荷まで一貫した試験を行っています。今回、応募している部門は、その中でも試験開発、実施している試験のコンプライアンスの確保を行っており、一般的な試験業務とは一線を画しています。試験に関する技術を取得されたい方は是非チャレンジしてください。工場はグローバル化が進んでおり、グローバル基準のGMPを経験したい、海外の方と業務をしてみたいという方にも是非。 工場の所在地は山口県光市です。自然豊かで、気候の穏やかな地域で、工場は瀬戸内海の海岸沿いに立地しています。山にも近く、自然を愛する方、自然の中でゆっくり過ごしたい方には絶好の場所です。 職務内容 分析法の開発、分析技術移管、申請書作成、局方改訂時のアセスメント、変更管理、逸脱調査など。 小グループのリーダー若しくはリーダー候補。

職務内容 以下の品質保証業務を担当頂きます。 開発プロジェクトのGMP遵守状況の監視 製造方法・試験方法の承認 治験薬出荷（製造記録照査を含む） 治験薬製造における変更管理 治験薬製造における逸脱・OOS/OOT・苦情の調査 サプライヤーに対するGMP監査ならびに品質契約の締結 継続的な品質システムの改善

職務内容 生物学的製剤の充填作業およびそれに伴う以下のような周辺関連業務 製造工程や設備のバリデーション／クオリフィケーション ワクチン製造に関わるドキュメントの作成 当局の査察の対応 生産トラブルの対応

職務内容 医薬品（ワクチン）の業務及び付帯関連業務 ・原材料・資材の在庫管理 ・秤量作業と緩衝液の調整 ・硝子製品の取り扱い ・洗浄・滅菌用設備の取り扱い ・アイソレーターを用いた無菌充填作業 ・製造設備の操作 ・設備メンテナンス計画の立案など

職務内容 ・CMCチームの目標および関連申請書類の承認を計画通りに達成する。 ・多様化するタケダの医薬品ポートフォリオのCMCライフサイクルマネジメント活動にプロジェクトマネジメントの専門知識を提供する。 ・高度にマトリックス化された環境において、部門横断的なチームを管理し、プロジェクト目標の達成を確実にする。 勤務地 大阪工場（光工場可） ※一部リモートワーク可

職務内容 音声およびビデオ会議のグローバルサービスチームのテクノロジースペシャリストとして、日本時間のプラットフォームの維持管理やプロジェクト推進や、サービスマネジメントを行います。バックエンドのクラウドサービスに加えて、会議室内に設置されるAV機器を適切に制御し、円滑な会議が可能なようサポートを提供します。 主な責任範囲 会議室AV機器会議インフラストラクチャを適切に維持管理する（主に日本国内） グローバルサービスチームと連携し、システム更新等を日本で円滑に推進する イベントサポートの提供（パートナーと協業したサポート体制の管理、自身のハンズオンサポート双方を含む） 会議インフラに関するテクノロジートレーニングやユーザーガイドを提供する 社内ITSMプロセスに準拠しインシデント、リクエスト、変更管理を行う 日本のビジネスユーザーの要望や相談窓口となり、必要な対応を進める

募集部門の紹介 タケダの国内最大工場で、医薬品原薬・医薬品を製造しています。その品質管理を行う部門で原料の受け入れから出荷まで一貫した試験を行っています。今回、応募している部門は、試験部門で試験を実施するのみでなく、チームリーダーを担うことができる方を求めています。将来的には一つのグループのマネージャーにチャレンジしてみたいという方に是非応募していただきたいポジションです。工場はグローバル化が進んでおり、グローバル基準のGMPを経験したい、海外の方と業務をしてみたいという方にも是非。 工場の所在地は山口県光市です。自然豊かで、気候の穏やかな地域で、工場は瀬戸内海の海岸沿いに立地しています。山にも近く、自然を愛する方、自然の中でゆっくり過ごしたい方には絶好の場所です。 職務内容 品質試験の実施、および品質試験のチームを率いる小グループのリーダー若しくはリーダー候補。