Santen is hiring a

[Japan] Pharmaceutical Technology Project Manager

Osaka, Japan
Full-Time

Global Technology Project Manager

  • Manage Life Cycle Management Projects, mainly global technology transfer projects related to new product introduction (NPI) and product transfer from one manufacturing site to another.
  • Manage projects according to defined processes and SOP (e.g. GLE, GPSS, etc.), and ensure project team members’ adherence and/or training to the processes.
  • Own the project end-to-end for the assigned scope.
  • Provide guidance and ensure that SMEs deliver activities on time, proactively escalate issues and conflicts to PSCT and functional leads for the duration of the projects.
  • Use state of the art project management techniques (Smartsheet, Risk Management tool, budget planning and controlling, resource management, reporting and escalation) to ensure projects are delivered according to plan, tracking key activities, ensuring visibility of the critical path and key decision milestones.
  • Run project activities in line with corporate codes of conduct, cGxP compliance, regulatory and financial integrity regulations, guidelines and requirements.
  • Ensure alignment and consistency with Global Manufacturing/ R&D CMC/ Supply Chain/ Quality Strategy/ Regulatory/ Technology groups/ Legal/ Finance objectives, including Corporate Management Goals and Policies.
  • Challenge the functions when justified to deliver and achieve project goals.
  • Prepare and deliver related presentations for senior management independently, as required.

Global Life Cycle Management

  • Develop or contribute to the deployment of global processes with other divisions, such as Global Launch Excellence (GLE) and Global Product Supply Standards (GPSS).
  • Continuously improve tools, processes, templates, and procedures for overall PPM contribution to GPS performance.

Program & Project Management Team

  • Contribute to the development of Program & Project Management organization by leading some initiatives that will allow PS to become “state-of-art” Project Management organization.
  • Use, promote, contribute to the development and deployment of tools / templates with Project Management Office Manager
  • Develop new Product Supply and PPM project Managers on new standards, including Project Management mindset and discipline.
  • Coach and develop peers for success as a team.
  • Ensure that Project Managers and SMEs manage projects according to our standards and best practices

Education

  • Master’s degree (or equivalent) in engineering or life science subject
  • Project Management (PMI or equivalent) certification

Skills

  • Fluent in English and Japanese (minimum)
  • Strong cross-functional communication and facilitation skills to manage the global processes
  • Advanced knowledge and hands-on experience of project management tools, like MS Project, Smartsheet, data analysis utilizing MS Excel, MS Power Point.
  • Solid understanding of end-to-end product supply processes, from product development to commercial product delivery to the patients.
  • Awareness of the sources of risks and subsequent appropriate mitigations management.
  • Sets clear expectations to functional teams and clarifies roles and responsibilities to manage the deliverables in a timely manner, respecting cultural and functional challenges, whilst maintaining focus on the project goals.
  • Negotiation skills and effective communication, pro-active and solution-oriented mind-set
  • Team player and able to take a leadership role in a multi-cultural work environment. Strong inter-personal skills, able to influence people in a matrix environment.
  • Self-starter, self-motivated, able to work independently, stress tolerant and flexible in approach.
  • 6S Lean Six Sigma Certification is a plus.

Experience

  • 8+ years proven experience in Project Management leadership and execution, (New Product Launches, Technology Transfers, Pruning, etc.), managing cross-functional teams to deliver projects on-time and on-budget.
  • Relevant work experience in a pharma/healthcare environment, preferably including working with team members located across JP and other continent(s).
  • Experience in a technical operations/product supply environment - supply chain management, production, new product introduction management (operational readiness), CMO management and/or site manufacturing.
  • Comprehensive know-how in pharmaceutical or chemical technologies such as API, Drug Product formulation (i.e., solutions, emulsions, and suspensions), filling and packaging.
  • Fundamental understanding of international regulatory cGxP requirements across multiple health authorities (e.g., US, EU, JP) - China is a plus.
  • Understanding of standard pharmaceutical manufacturing processes, analytical testing, and methods development

(業務内容の変更の範囲)当社業務全般
(就業場所の変更の範囲)本社および全国の事業所、営業所

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