Associate Director, Global Master Planner, Supply Chain Management / サプライチェーンマネジメント部 グローバルマスタープランナー

【職務内容】 ステークホルダから要件をヒアリングの上でエンジニアリング会社などと原薬・バイオ製造設備、製剤・包装設備のF/S, FEEDを行いプロジェクトリードとして設備計画を取りまとめる。小規模なプロジェクトでは自身が基本設計を行う場合がある。 設備計画が承認された際には引き続き競争入札の上でEPCを実施してコミッショニング、クオリフィケーションを行いPQ以降の工程を技術/現場/保全部門へ引き継ぐ。 生産設備や用役設備の中長期的な計画を策定・管理を行うことでサイト戦略を立案する 品質保証に関する業務を理解して必要なドキュメントの作成、レビューを行うとともに各域当局、グローバルエンジニアリング組織からのガイダンスを確認して既設設備の評価を行う。 Responsibilities: The department supports the lifecycle (installation, startup, operation, and renewal) of all Hikari facilities. After hearing requirements from stakeholders, conduct feasibility studies and concept designs for formulation/packaging, bio/pharmaceutical production facilities and service facilities, and compile facility plans. The site strategy is developed by formulating and managing mid- to long-term plans for production facilities and service facilities. Planning, drafting, designing, giving production instructions to suppliers, commissioning, and qualification of production facilities for solid and sterile drugs, packaging, or biotechnology and active pharmaceutical ingredients, and guiding the facilities. The candidate will be responsible for the planning, drafting, designing, giving manufacturing instructions to suppliers, commissioning, qualifying, and guiding the equipment.

Responsibilities 1. Collaborate closely with pharma science, regulatory, and quality control organizations, as well as process experts across our global plasma network. 2. Provide leadership and guidance to team members, assisting them in prioritization, problem resolution, and process clarification. 3. Direct the effective transfer of technology from design development to implementation. 4. Evaluate the suitability of new technologies for implementation and transition to the manufacturing floor. 5. Ensure successful product technical transfer to the new plasma facility. 6. Establish reliable yield status and accurate yield forecasts for all transferred products, implementing strategies to meet yield targets. 7. Develop and direct strategies for yield improvement projects, lead time reduction, process security, and deviation reduction. 8. Assure process robustness and supply reliability by controlling the manufacturing process life cycle. 9. Develop strategic plans that incorporate regional and global business practices and customer needs. 10. Define and communicate strategic imperatives for project success, including market entry timing, innovative technology, and costs. 11. Develop effective tech transfer project milestones, schedules, and manage budgets. 12. Utilize state-of-the-art project management tools to ensure project schedules and budgets are met. 13. Identify and resolve issues that may impact project schedules or improve project time. 14. Understand and effectively communicate market niche and competitive forces influencing the project. 15. Ensure team objectives align with key tech transfer projects for the new facility. 16. Proactively prioritize and balance resource utilization for the project. 17. Select, develop, and retain staff, providing constructive feedback, recognition, coaching, mentoring, and motivation. 18. Generate innovative solutions to complex problems using multiple disciplines and technical principles. 19. Create innovative products, processes, and methods through novel combinations of expertise within the organization. 20. Perform other duties as assigned. Qualifications 1. Utilize your strong scientific background to contribute to the development and optimization of plasma manufacturing processes. 2. Apply your knowledge of GMPs, FDA, EMA, PMDA, Lean, Six Sigma, and DMAIC methods to ensure compliance and continuous improvement. 3. Demonstrate self-motivation, strong interpersonal skills, and the ability to analyze and solve complex problems through innovative thought and experience. 4. Utilize project management tools to effectively manage multiple cross-functional teams simultaneously. 5. Design and implement projects/studies outside your area of expertise, leveraging your scientific knowledge and skills. 6. Provide strategic leadership and supervision to ensure the success of process development and tech transfer projects. 7. Utilize your experience in change management to drive process improvement initiatives. 8. Demonstrate a high level of customer orientation and organizational skills. 9. Embrace a flexible and innovative mindset, thinking outside the box to drive continuous improvement. 10. Communicate effectively, both verbally and in writing, to convey complex scientific concepts and project updates. 11. Leverage your record of success in process development, tech transfer, project management, and regulatory submissions to drive the success of our plasma manufacturing processes. 12. Collaborate with cross-functional teams in a highly matrixed, cross-functional, and geographically dispersed environment. 13. Utilize your experience in GMP inspections to ensure compliance with regulatory requirements.

OBJECTIVES/PURPOSE Leads team that ensures uninterrupted delivery of Safe, Sustainable, Resilient, Reliable, Compliant Plant Utilities (GMP and non-GMP) and Infrastructure to the manufacturing plant Support Global Sustainability Program objectives through the development of long range carbon/energy/water/waste reduction plans and deliver project portfolio of engineering solutions to meet the Site’s Environmental Sustainability goals and objectives ACCOUNTABILITIES Responsible for all black utility functions in the Plant: Utilities operations, Utilities Maintenance, Sustainability Engineering and Plant Engineering Accountable owner of site carbon project portfolio and long-range plan (MRP) in partnership with the Site EHS Sustainability Lead Monitor and report the Site’s carbon, energy, and water consumptions, identify trends and measure the effectiveness of sustainability engineering projects Leads, develops, and trains high performing utilities & facilities function and staff Member of the site engineering leadership team Owner for site utilities and facilities operations and maintenance budget and long-term asset management plan Primary site point-of-contact for internal and external carbon assessments Delivers site carbon operating mechanisms, goals/KPIs, and communication plan DIMENSIONS AND ASPECTS Interaction EHS Sustainability Lead, Utilities/Facilities Operations, Plant Engineering, Automation, Contractors, Consultants, CAPS Community of Practice

OBJECTIVES/PURPOSE Responsible for designing, developing, and maintaining electrical and automation systems. The successful candidate will work closely with cross-functional teams to ensure that all electrical and automation systems are in compliance with regulatory requirements and industry standards. Project engineering for the Strategic Automation Pillars in the areas of: Automation Security & Integrity Engineering Automation & Control Systems Data Integrity Automation Cybersecurity Automation Solutions & Systems Engineering Functional setups & architectures of systems & components Supervisory Control Structures & Data Mgt. Automation Data Engineering Standard Automation Integration Layer (Shopfloor Systems & Data Integration) Data Channels, HMI, displays & Visuals Historization Automation Data Governance Engineering Data Structures & Contextualization Use Case Owner Liaison Mgt, Technical2Business (and vice versa) translation ACCOUNTABILITIES As a member of the Engineering workstream of the project, provides guidance and leadership to all automation-related activities in accordance with the Global Automation Strategy. In detail, He/she will: Report to the engineering manager. Develop and maintain automation guidelines and standards based on project approved budget and schedule, and ensure compliance Ensure that all automation systems meet regulatory requirements, client specifications, and industry standards and define the user requirements. Ensure compliance with Automation Standard Requirement Specification, Automation Engineering Guideline, compliance, and cybersecurity in the project. Collaborate with other project disciplines to ensure integrated design solutions. Guide and coordinate with external design company the procurement strategy packages definition related to its discipline. Review and approve automation documents and concepts. Conduct gate keeping reviews. Review and approve contractor submittals.