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エージェント取り扱い求人
品質薬事担当

・国内外の薬事規制要件を理解した上で、申請資料の品質パート作成における薬事戦略を策定する。 ・社内、または製造所とコミュニケーションを取りながら、CMC薬事課題の抽出・相談・解決を行う。 ・CMC技術部門関係者と連携し、申請資料の作成を推進する。 ※ご経験に応じて、お任せする業務内容が変更する場合がございます。 ※フルタイム、パートタイムの選択可能です。

  • 900万〜1500万
  • 東京都
  • 再生医療・バイオベンチャー

募集中

エージェント取り扱い求人
法人営業

DCT Japanが持つソリューションを活用し、国内外の大手~ミドルクラスの製薬企業に対する営業職です。 製薬企業の臨床開発部門並びにメディカルアフェアーズ、CRO(国内・海外)に対して、DCTや臨床研究における当社ソリューションの活用を提案し、受注を目指していただくものです。 看護師プールがあり効率的なビジット対応が可能なこと、インテグリティ・ヘルスケアグループが持つプラットフォームやネットワークがあることが他社にない強みです。 患者の来院に依存しない臨床試験が広まることで、当社グループが目指す個別医療を実現するとともに、売上の最大化を目指します。 国内営業担当1名、海外営業担当1名、合計2名を募集します。 具体的には・・・ ・既存取引先や、ディスカッション実績がある企業、あるいはそれらの企業からの紹介、インテグリティ・ヘルスケアとの顧客連携などにより新規案件を獲得します。 ・ほとんどの商談はリモートで行います。クライアントの要望があれば対面で実施します。 ・1案件あたり数百万~1億円以上の提案で、セールスサイクルは3カ月~半年程度となります。 【働き方】 在宅中心 海外営業担当の場合、現地時間に合わせての打ち合わせがあります。

  • 400万〜600万
  • 東京都
  • ヘルステック

募集中

エージェント取り扱い求人
Head, Commercial Vaccines Quality, Japan

ACCOUNTABILITIES The role is accountable for the overall quality strategy and quality management system of commer-cial vaccines operations and supplies in Japan. The Head of commercial Vaccines Quality is respon-sible to design, deploy, monitor and improve the quality management system and for compliance to current Good Manufacturing/Distribution & Laboratory Practices and compliance to Takeda global standards and overall Hikari Site Standards. The Head of commercial Vaccines Quality partners with the GMS site quality head and aligns on site quality strategy, a harmonized cross-plant quality philosophy & joint quality initiatives and main-tains good day to day collaboration between the 2 site quality organizations. Ensures that new/revised quality system requirements are deployed to the site timely. Ensures execution leads for Quality-owned business processes are established who work with the business process owner to continually execute compliantly & improve on site processes. Responsible for Japan vaccine quality performance, continuous improvement and Q-metrics (KPI) monitoring to ensure global and site targets are achieved, met and countermeasures are in place when applicable. Responsible for Quality Control testing and sampling for commercial vaccines (Bulk Drug Substance and Drug Product (BDS, DP)) and partners with other Takeda laboratories or external laboratories for testing that is performed on behalf of vaccines quality (eg. Microbiology, Environmental Moni-toring, Raw Materials) Responsible to establish the appropriate quality oversight for outsourced activities such as testing as well as quality assurance review of site validation activities. Development and refinement of groups’ specific quality systems and procedures. Committed to continuous improvement and responsible to proactively mitigate current and future risks to maintain an effective operation to support business needs. Living Takeda’s values (Takeda-isms) and fostering a Quality Culture culture of trust and and speak up culture within the team. Assuring appropriate GMP and QA systems training of Quality personnel and continuously develop team´s capabilities and expertise. Accountable for quality oversight of site quality management systems (CAPAs, Change Controls, Deviations, Formal Risk Management, facility/equipment/process qualification) Responsible for site specific QMR management and gathering of APQR data. Align with GMSGQ team and provide QA support for electronic system integration: LIMS, Trackwise, SAP etc. Responsible for vaccine batch disposition decisions taking into account all relevant information and escalation processes. Oversight of execution of product disposition (drug substance). Responsible to ensure sufficient and adequate quality oversight of vaccines manufacturing and distribution processes. Preparing for/ supporting/ leading internal and health authority regulatory inspections and third-party audits, including communicating with and providing information to regulatory submissions or bodies. Responsible for timely updates of site achievements and challenges to management with a focus on quality compliance, operations performance, staff performance and productivity/training, staff development, continuous improvements, key projects support and identification and resolving obstacles to maintain a highly effective and productive functional group. Responsible for management of cross-plant quality issues and timely escalation of vaccines related issues within the global Takeda VBU organization. Responsible for budget planning and managing expenses and for timely hiring, training and devel-opment of qualified staff to ensure effective execution of roles and responsibilities, GMP compli-ance, and attainment of operational and development goals.

  • 1300万〜1700万
  • 山口県
  • 医薬品メーカー(先発医薬品)

募集中

エージェント取り扱い求人
CAPEX Project Director, Japan New Plasma Facility Project

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 Takeda 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 Takeda 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.

  • 1300万〜1700万
  • 大阪府
  • 医薬品メーカー(先発医薬品)

募集中

エージェント取り扱い求人
Manager or Specialist, Vaccine DP Development / ワクチン製剤技術研究 担当者または課長代理

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

  • 500万〜1300万
  • 山口県
  • 医薬品メーカー(先発医薬品)

募集中

エージェント取り扱い求人
Microsoft 365 Engineer

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.

  • 500万〜800万
  • 東京都
  • 医薬品メーカー(先発医薬品)

募集中

エージェント取り扱い求人
Associate Director or Manager, Chief of Staff Office

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

  • 900万〜1700万
  • 東京都
  • 医薬品メーカー(先発医薬品)

募集中

エージェント取り扱い求人
Associate Scientist/Principal Scientist, Process Engineering, Pharmaceutical Science

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 Takeda and 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

  • 900万〜1300万
  • 神奈川県
  • 医薬品メーカー(先発医薬品)

募集中

エージェント取り扱い求人
Associate Director Process Engineering

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 Takeda and is an active member on pre-competitive collaborations with academic and industrial partners.

  • 1300万〜1700万
  • 神奈川県
  • 医薬品メーカー(先発医薬品)

募集中

エージェント取り扱い求人
ワクチン製剤製造スタッフ(包装/契約社員)

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

  • 300万〜万
  • 山口県
  • 医薬品メーカー(先発医薬品)

募集中

エージェント取り扱い求人
Utility Engineer, Japan New Plasma Facility Project

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.

  • 600万〜1000万
  • 大阪府
  • 医薬品メーカー(先発医薬品)

募集中

エージェント取り扱い求人
Platform Engineer - Data Solutions_ID:577

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 Takeda strategy to become a Data Driven Enterprise. By connecting with Business Units and Business Functions within Takeda’s 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 Takeda 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.

  • 500万〜800万
  • 東京都
  • 医薬品メーカー(先発医薬品)

募集中

エージェント取り扱い求人
Program and Project Manager/プロジェクトマネージャー(ID:551)

【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

  • 1300万〜1700万
  • 大阪府,東京都
  • 医薬品メーカー(先発医薬品)

募集中

エージェント取り扱い求人
Vaccine Testing Project Staff, Quality Control / ワクチンの試験技術・マネジメントスタッフ

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

  • 500万〜800万
  • 山口県
  • 医薬品メーカー(先発医薬品)

募集中

エージェント取り扱い求人
Vaccine Environmental Monitoring Staff/ワクチン環境モニタリング担当者(正社員/契約社員)

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。

  • 300万〜万
  • 山口県
  • 医薬品メーカー(先発医薬品)

募集中

エージェント取り扱い求人
ワクチン原薬製造担当者(契約社員)

職務内容 タケダでは、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。 タケダは約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、そしてタケダイズム(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

  • 300万〜万
  • 山口県
  • 医薬品メーカー(先発医薬品)

募集中