求人情報一覧

ACCOUNTABILITIES Develop and manage project budgets, ensuring that all expenditures are in accordance with approved budgets. Manage project risks, ensuring that risks are identified, assessed, and mitigated in a timely manner Provide regular project status updates to senior management and other stakeholders. Ensure compliance with all applicable regulations, guidelines, and policies. Provide regular management up-dates and act as an enabler for individual project teams. Use project management methodologies and skills to manage the capital project across organizational boundaries and is responsible for its successful delivery. Ensures the project is conducted at the highest quality, within time and budget, and that the risk level and stakeholder expectations are managed. Ensures adherence to the GMS GOP - Planning and Execution of Capital Investment Projects Coordinates and supervises project execution related activities, from initiation to close out and successful hand-over. Leads a cross functional team of internal and external specialists. Responsible for meeting project scope requirements, schedule requirements, and costs. Interfaces with major projects/initiatives at the specific plant. Transfers best practices across functions and business units as well as other sites. Ensures compatibility and consistency with the existing organization and industry standards (PMM, cGMP, GEP, etc.) Coordinates with all stakeholders, facilitates problem solving sessions and or other planning sessions, and makes adjustments to the project in alignment with the overall business strategy. Responsible for the adequate utilization of all quality systems as defined by Procedures within the project organization. Ensures appropriate safety measures are taken to prevent injuries and minimizes safety risks. Ensures readiness for inspections together with quality organizations. Ensures compliance with rules and regulations of procurement and accounting. DIMENSIONS AND ASPECTS Project CAPEX Size of project: about 1000 Oku Yen Technical/Functional (Line) Expertise Knowledge of manufacturing processes and engineering documents, such as facility layouts, P&IDs, equipment arrangements, facility design, and facility costs. Knowledgeable in project management methodologies (i.e.PMBOK, PMI etc.). Awareness of current state of the art in the field of pharmaceutical engineering and biotechnology and familiarity with GMP and other regulations. Knowledgeable in project controlling and scheduling Leadership Influencing and collaboration skills. Leadership and problem solving skills. Foster a culture of collaboration, continuous improvement, and innovation among project teams. Decision-making and Autonomy Within his/her area of expertise as defined at the project start. Interaction Experience working in large company environment with matrix organizations. Experience in working and communicating globally in the pharmaceutical or biotech industry. Anticipates and resolves conflict situations in a win-win outcome. Team based player. Innovation Evaluates and proposes innovative project delivery methods where applicable. Translate innovation initiatives across into project execution and design. Complexity Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience.

職務内容 以下のワクチン注射製剤の製剤開発に関する業務に従事頂きます。 製剤設計（処方、剤形の設計） 製剤製造プロセス設計（治験段階～商用に応じた製剤製造法の開発） バリデーション、治験薬製造設備・機器の管理、治験薬製造・供給 商用スケールへのスケールアップ検討、商用部門への引き継ぎ 申請書類の作成、照会事項対応、査察対応など

Microsoft 365 Administration: Ensure data integrity and security by evaluating, implementing, and managing appropriate Microsoft 365 hardware and software solutions utilizing industry standards and best practices. Manage Microsoft 365 licenses, subscriptions, and users across the organization. Provide technical support to end-users to resolve any issues and/or fulfill user's requirement related to Microsoft 365 services. Interact with end-users directly to capture the user's demand via multiple communication channels, including face-to-face, remote session, and email/chat . Deploy Microsoft 365 software installations, configurations, and upgrades across a diverse customer base. Ensure compliance with established standards, policies, best practices, and configuration guidelines. Develop and document standards and procedures for Microsoft 365 administration and maintenance. ITSM Incident, Request, and Change Management: Manage and respond to Microsoft 365 incidents and service requests using IT Service Management (ITSM) tools and processes. Collaborate with the ITSM team to plan/test Microsoft 365 related changes to minimize business disruptions complying with the standard change management policies. Develop and maintain Microsoft 365 service processes and documents for incident, request, and change management. Ensure timely resolution of Microsoft 365 incidents and service requests to meet the expected service level and minimize impact on end-users.

Responsibilities include: Manage day to day Chief of Staff Office responsibilities ensuring a smooth operation and coordination in GCA Lead as a point of contact for GCA members and other stakeholders, representing the Chief of Staff Office and directly supporting the Chief Global Corporate Affairs and Sustainability Officer Work with GCA Leadership Team (GCALT) and Finance Business Partner to monitor and track the budget spending vs plan Lead GCA-wide strategic initiatives and employee engagement activities, including facilitation, troubleshooting stakeholder management and decision making Contribute to key GCA priorities including corporate communications, sustainabilty, and public affairs Lead preparation and facilitation of the GCA monthly meetings and Townhalls Lead Chief Global Corporate Affairs and Sustainability Officer’s presentation development and coordination Support Chief of Staff and Head of Global CSR and Partnership Strategy with additional tasks as needed

Accountabilities: Develops project or significant technical strategy and leverages technical skill(s) as a resource/expert within the department Contributes significantly and independently to project work which may include multiple projects within functional area. Plans and implements resolutions to technical problems/issues Independently designs and executes experiments, and reports results Recommends, justifies and implements technologies and innovations. Owns a discipline/technical skill in its entirety and continues to develop expertise in other key technical skills. Influences and supports initiatives related to driving scientific and technical improvement within function and potentially cross-functionally. Reviews, interprets and communicates data cross functionally within pharmaceutical sciences and project teams Conducts analysis of technical and conceptual risk and trends Identifies process trends and defines/champions process strategy or use of novel technologies Recognized as a technical expert and resource within function Significant technical responsibility for a project area/technical program within the department and potentially across Pharmaceutical sciences Identifies topics for initiatives and leads local/global initiatives on behalf of senior staff. Defines appropriately complex/novel approaches and methodologies to solving outstanding technical challenges Coordinates and leads technology transfer to internal or external manufacturing sites Responsible for authoring relevant sections of regulatory documents, validation plans, reports and peer reviewed manuscripts. Proactively identifies vendors and builds relationships to gain access to technologies as needed to deliver on pipeline goals. Manages key vendor relationships across multiple projects as appropriate, and proactively affects resolution of issues arising at vendors. Represents is an active member on pre-competitive collaborations with academic and industrial partners. Education and Experience: A Ph.D. degree with 3+ years of academic, post-doctoral or pharmaceutical industry experience; an MS degree with 9+ years of pharmaceutical industry experience; or a BS degree with 11+ years of pharmaceutical industry experience. Degrees in chemical engineering required. Experience in the use of mathematical, both statistical and first principle, models as well as advanced process control systems preferred Experience in building reaction kinetic models as well as process models preferred. Experience in building laboratory and pilot plant equipment a plus Experience in crystallization process development and scale-up with an emphasis on form, purity, and particle size control a plus Experience in the use and scale-up of milling technologies (both dry and wet) for particle size control a plus Experience in the use of process analytical technologies (FT-IR, NIR, FBRM, UV-vis, etc.) required Experience in building chemometric models preferred Experience in developing continuous processes a plus Sound knowledge of current Good Manufacturing Practices (cGMP) preferred Experience working in a pilot plant a plus Previous experience with the use of contract facilities and managing technical transfers a plus Experience in working in a multi-disciplinary team environment Proven scientific track record through presentations at scientific conferences and publication of pier reviewed manuscripts

Accountabilities： Leads and manages a group of Engineers, providing technical guidance, mentoring, and performance management to ensure the team's success and professional growth. Develops project and/ or significant technical strategy and leverages technical skill(s) as a resource/expert within the department. Collaborates closely with cross-functional teams, including process chemistry, analytical development, drug product development, manufacturing, quality assurance, and regulatory affairs, to develop and implement effective process engineering strategies. Drives process optimization initiatives to improve sustainability, process efficiency, yield, quality, and cost-effectiveness, utilizing expertise in process chemistry and fundamental engineering principles. Oversees process scale-up activities from laboratory to pilot plant and commercial-scale production, ensuring smooth technology transfer and process validation. Has full accountability for all engineering aspects for multiple pipeline projects. Initiates complex projects with extraordinary technical challenges and applies strong technical risk assessment skills. Owns a discipline/technical skill in its entirety and continues to develop expertise in other key technical skills. Contributes significantly to develop, drive and set the vision and direction of departmental activities, management of resources, time, personnel and financial resources. Maintains ownership of overall vision of scientific platform. Communicates and coordinates implementation of technology/scientific improvement to senior management, across therapeutic and scientific areas. Conducts analysis of technical and conceptual risk through robust process characterization, failure mode analysis, and risk assessment methodologies, identifies trends and defines and champions process or scientific strategies. Incorporates novel manufacturing, technologies and industry trends as a key aspect of scientific strategy development. Maintains complete technical responsibility for program(s)/initiative(s) within the department. Leverages cross functional knowledge to guide pharmaceutical sciences teams on potential impact of actions across projects, particularly in technical aspects. Ensures effective project management of all plans and projects within area of responsibility, linking all scientific efforts to company, program and functional goals. Leads small working groups as appropriate to address knowledge gaps in programs linking departmental strategy to strategies of other relevant functions. Identifies topics for initiatives and leads local/global initiatives on behalf of senior staff. Recognized as a technical leader/resource by the group and fosters development of technology skill sets within department and among junior staff. Contributes to departmental strategy around scientific improvement and new capabilities. Makes proposals regarding sourcing/consultancy strategy. Coordinates and leads technology transfer to internal or external manufacturing sites or vendor Communicates with senior management of other functions on implementation of infrastructure, technology, work processes, or business processes. Responsible for authoring relevant sections of regulatory documents, validation plans, development reports, process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), process descriptions and peer reviewed manuscripts. Defines outsourcing strategy for department in conjunction with senior staff. Proactively identifies vendors and builds relationships to gain access to technologies as needed to deliver against pipeline goals. Manages key vendor relationships across multiple projects as appropriate, and proactively affects resolution of issues arising at vendors. Represents is an active member on pre-competitive collaborations with academic and industrial partners.

職務内容 医薬品（ワクチン）の製剤製造（包装）業務及び付帯関連業務

OBJECTIVES/PURPOSE Deliver optimal designs, operating procedures and maintenance programs for GMP and non-GMP Plant Utilities Systems / Critical Systems / Site Infrastructure Systems Maintain accurate, consice, effective, up to date operating procedures and maintenance plans for Plant Utilities Systems / Critical Systems / Site Infrastructure Systems Drive continuous improvements through defect elimination in System Design, Operations and Maintenance program and processes Support Sustainability initiatives related to Plant Utilities Systems (e.g. energy, water, waste reduction) ACCOUNTABILITIES Acting as a Plant Engineer in the Engineering workstream of the project and being the project point of contact with the engineering company for utilities (black and clean) and sustainability related activities. In detail, He/she will: Report to the Engineering Manager. Develop and maintain utility concepts and engineering scope based on the approved budget and schedule. Ensure that all utility systems meet regulatory requirements, client specifications, and industry standards and defines the user requirements. Collaborate with other project disciplines to ensure integrated design solutions. Guide and coordinate with the external design company on the procurement strategy and procurement packages definition related to its discipline. Review and approve design documents and concepts. Conduct gate keeping reviews. Review and approve contractor submittals. Manage the resolution of technical issues.

The Opportunity As a Data Platforms Engineering leader, you'll have a business Impact and direct alignment to the Head of Data Platforms and Architecture vision. The role is a key enabler for strategy to become a Data Driven Enterprise. By connecting with Business Units and Business Functions within Global Business and with their data teams, the data platform lead will strategically architect data, processes, and technology to achieve faster time to market for life saving products. Ultimately, help to make better decisions that improve the quality and efficiency of care for patients. You will develop data driven solutions utilizing current and next generation technologies to meet evolving business needs. You will quickly identify opportunities and recommend possible technical solutions and you will develop application systems that comply with the standard system development methodology and concepts for design, programming, backup, and recovery to deliver solutions that have superior performance, reliability, and integrity. As part of our transformational journey on Data & AI in Operations, we are taking the steps to advance to Data Mesh architecture. The current Datalake exists to give all Operations units access to critical data and analytic tools at pace, accelerating their work on life saving medicines. The vision of EDS is also accelerating Operations’ data strategy of making our data Findable, Accessible, Interoperable, and re-useable. This is being achieved through the creation of a distributed data architecture, management of our data and data products which will sit as a centerpiece of this strategy and the future evolution of Data Science. Responsibilities Create best practices and thought leadership content to be used by the federated delivery teams building data solutions and data products on Enterprise Data platforms that cater to batch, streaming and real-time data. Influence stakeholders at all levels through complex engagement models with the wider cloud ecosystem not limited but inclusive of AWS foundations for Infrastructure and data technologies, Databricks, Informatica, Kafka, Managed File Transfer, and 3rd party applications, ensuring they are excited by the Enterprise Data Services vision and solution strategy. Be a 'champion’ for both customers and colleagues by operating as an expert Engineer and trusted advisor for significant data analytics architecture, design, and adoption and scaling of the Datalake platform. Provide a roadmap for modernizing legacy capabilities inherent to the current platform. Support all data platform initiatives – Data Lake Strategy, Data Engineering and Platform development, Data Governance, Security Models, and Master Data Management. Establish a collaborative engineering culture based on trust, innovation, and a mindset of continuous improvement. Utilize Industry best practices and agile methodologies to deliver solution and extract efficiency through automations in Continuous Development and Continuous Integration. Manages efforts to problem solve for engineering challenges and coordinate with project consultants and delivery/engagement managers. As a leading technical contributor who can consistently take a poorly defined business or technical problem, work it to a well-defined data problem/specification, and execute it at a high level. Have a strong focus on metrics, both for the impact of their work and for its engineering and operations. Understand the Data Platforms investments and create data tools for consumption of services and uncover opportunities for cost optimization to assist the team in building and optimizing our platforms into an innovative unit within the company. Skills and Qualifications Bachelor’s degree or higher in Computer Science/Information technology; or relevant work experience.

【Accountabilities】 ステークホルダーマネジメントとして、サービス提供のパフォーマンスを監視し、ステークホルダーに可視化し、報告すること プロジェクトメンバーに対して全体的な戦略、計画、管理指導を行うこと プログラム/プロジェクトのスコープ、スケジュール、コスト、品質を管理し、顧客/ビジネスの戦略性、要件との整合性を確保すること 顧客/ビジネス、製品/プラットフォームオーナー、テクノロジービジネスパートナーと連携し、顧客/ビジネスの戦略的ニーズを満たすテクノロジーサービスを特定すること 主要なステークホルダーとステータス、リスク、成果について積極的にコミュニケーションを図り、プロジェクトを確実に成功させること リソースの透明性を提供し、相互依存関係を管理すること。そして、積極的にエスカレーションを行い、影響を伝えること プログラム/プロジェクトのビジネス/ステークホルダーと積極的にコミュニケーションし、プロジェクト阻害要因を解決し、プロジェクトをリードすること プロジェクトの成功要因が、より広範なプログラムとどのように関連しているかを理解し、最適な結果を確実に提供すること プロジェクトが、適用されるガバナンス方針およびプロセスを理解し、遵守していることを確認すること プログラムとプロジェクト活動を常に監視し、合理化することで、最大限の価値が提供されるようにすること 標準化されたプロジェクトマネジメントのベストプラクティスとプロセスの作成、関係者へ正しく適用され、運用できる様に貢献すること

職務内容 • ワクチン商用製品、治験薬の 試験技術・マネジメント または補助業務 • 国内外関連部門、提携先からの試験法技術移転、技術的サポート • 製造部門との協働、試験サポート管理 • 国内外の試験受託機関への試験法技術移転、試験マネジメントなど

職務内容 SOPに従いGMP製造エリアでの微生物サンプリング、微粒子サンプリングを含むグレードA～Dクリーンルームの環境モニタリング業務を実行する。 水、蒸気などのクリーンユーティリティーの定常的サンプリング業務を実行する 文書改訂業務、計画書作成または修正時に支援をする。 環境モニタリング計画に従って環境モニタリングを実行する。 逸脱等に対する根本原因の調査を行い、是正・予防計画を含む調査報告書を作成する。 質問や提案を推奨する「Speak Up」を実践する。 環境モニタリング業務や製造エリアの環境に関する改善提案を行う。 コンプライアンスに関する問題を上申する。

職務内容 常に患者さんを中心に考え、その生活を豊かにするためにイノベーションを推進しています。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組んで取り組んでいます。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。 約5万人の従業員が、約80の国や地域で働くグローバルな企業です。すべての従業員が世界中の人々の生活をより良いものにしたいという信念をもち、そしてイズム（誠実：公正・正直・不屈）を日々の業務で体現しています。私たちは、240年以上の歴史を持つ研究開発型の製薬企業としての伝統のもと団結し、優れた医薬品の創出を通じて、人々の健康と医療の未来に貢献することをミッションとして掲げています。 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 生産トラブルの対応

仕事内容: 経営企画部門のITシステム担当者として、部門のデータ・デジタル活用を推進いただきます。そのために、ユーザエクスペリエンスの視点とＩＴ組織全体の戦略の両方の視点を持ってプロセス&システム全体を幅広く理解し最適な提案を行うとともに、責任を持ってソリューションの導入・運用を推進いただきます。 主な内容は以下の通りです。 ビジネス部門の関係者と協働してデータ・デジタル活用のニーズを収集するとともに、IT化のロードマップ・実行計画を策定する データ・デジタルの活用による、新たなビジネスプロセスの創出支援および既存のビジネスプロセスの改善をリードする IT部門が所管している、経営企画部門向けの専用アプリケーション・ソフトウェア（以下）を適切に管理し、安定稼働に必要な保守・運用、システム開発を主導する -経営会議サポートシステム（仮称：開発中） -経営理念ダッシュボード （MS Power BIベースのアプリケーション） -BSCアプリ（MS Power Platformベースのアプリケーション） 国内外のIT部門関係者と密に連携し、グローバルプラットフォームやアプリケーションの日本展開を支援する。また、関連するインフラおよびセキュリティ対応の実施を支援する ビジネス部門のゴール達成に役立つような、新たなテクノロジー関する知識を収集し応用する ビジネス部門のステークホルダーのデジタル デクステリティ向上に必要な施策を検討・実施する

職務内容 消化器及び炎症性疾患（GI and Inflammation）領域の主に日本における臨床試験に関する下記業務 開発戦略・ライフサイクルマネジメント戦略策定、開発計画立案 臨床試験計画立案と実施 臨床試験成績の医学的及び科学的評価 製造承認申請業務 治験相談に係る戦略の策定 導入案件・開発候補品目の医学的及び科学的評価 社外ステークホルダー（専門家、規制当局など）との交渉

【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 • 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