Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people around the world.

The position will manage global technology projects and develop global life cycle management processes in Global Product Supply (GPS).

1. Global Technology projects
   • Manage global technology transfer projects related to new product introduction (NPI) and product transfer from one manufacturing site to another, in accordance with Santen Global Launch Excellence (GLE) & Global Product Supply Standards (GPSS) processes.
   • Lead the projects’ cross-functional teams to execute the planned activities and deliver the set objectives in time and in full, in the planned regions and in alignment with R&D / Commercial defined plans and Product Supply strategy
      
2. Global processes
   • Develop or contribute to the design and/or deployment of global operating processes such as Global Launch Excellence (GLE) and Global Product Supply Standards (GPSS), in close collaboration with GPS cross-functional business partners or other divisions.
      
3. Program & Project Management (PPM) Team
   • Lead project management excellence initiatives to create and/or continuously improve PPM project standards and new “way of working”.
      
4. Other
   • Contribute to Product Supply business cases evaluation for strategic decisions

The role for Global Technology Project Manager

• Manages Life Cycle Management Projects, mainly Global technology transfer projects related to new product introduction (NPI) and product transfer from one manufacturing site to another.
• Manages projects according to defined processes and SOP (e.g. GLE, GPSS, etc.), and ensure project team members’ adherence and/or training to the processes.
• Owns the project end to end for the assigned scope.
• Provides guidance and ensures that SMEs deliver activities on time, proactively identifies and escalates any delays, challenges, conflicts to Project management to PSCT and  functional leads in case of encountered issues for the duration of the projects.
• Uses 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.
• Runs project activities in line with corporate codes of conduct, cGxP compliance, regulatory and financial integrity regulations, guidelines and requirements.
• Ensures 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.
• Challenges functions when justified to deliver and achieve project goals.
• Prepares and delivers related presentations for senior management independently, as required.

The role for Global Life Cycle Management processes

• 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.

The role for 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

Qualification, Skills

• Fluent in English and Japanese (minimum)
• Strong cross-functional communication and facilitation skills to manage the global processes
• Advanced knowledge and on-hands 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.
• Exposed to pharma/healthcare environment, preferably including working experience 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