Santenは、眼科医療に特化した130年の歴史を持つ製薬企業です。日本発のグローバル企業として60カ国以上に拠点を持ち、目の健康のために様々な革新的な治療法とデジタルソリューションを提供し、世界中の人々の視覚に関わる社会問題に取り組んでいます。

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.

As a key partner to the business, the Head of External Manufacturing and Sourcing (EM&S) is responsible for the strategic planning and execution of EM&S operations across three of Santen’s Regions (Japan, China and Asia).

This position leads and manages the manufacturing, sourcing and Contract Manufacturing Organisations (CMOs) for all Santen products produced externally within the Region.  Additionally responsible for assessing new business development opportunities and for developing and implementing the required organization, standards, processes and procedures.

The position reports to the Head of Global EM&S and is responsible for delivering overall performance results from the Regions’ CMO network.

<Key Activitries & Accountabilities>

• Drives and develops the regional EM&S vision in partnership with global EM&S, for pharmaceutical and biologics CMOs
• Develops the strategy for EM&S across the Region, with direct accountability for external manufacturing operational performance, including on-time in-full supply, COGS management, capacity management and business continuity planning.
• A key member of the Product Supply (PS) department, provides strategic input and ensures alignment with senior stakeholders to ensure the attainment of the company’s short- and long-term goals.   
• Implements and leads Supplier Relationship Teams (SRTs) to manage the key strategic partners, acting as the virtual plant manager for the CMO, with matrix responsibility for cross-functional team members such as Quality, Planning, Procurement, Project Management and MS&T.  Ensures optimal supplier relationship management and the seamless delivery of products to meet the needs of the business.
• Negotiates and runs RFPs to ensure the continuity of product supply requirements and delivers timely execution of Technical Transfer projects, for existing and new product launches.
• Leads external manufacturing and sourcing in a cost-efficient manner, developing quantitative performance monitoring and the rollout of relevant KPI’s that can be used as a platform to continuously improve supply from external manufacturers.
• Builds a quality ethos into all decisions and processes, reinforcing the implementation of Santen’s Global Tech Transfer Process (GTTP) standards to support Make-or-Buy decisions, Supplier Selection, Technology Transfers and the Management of Commercial Products. 
• Owns and controls the regional EM&S budget including capital investments with external partners, technical transfer expenses and other expenses needed to support the life cycle management of the products.
• Drives change management and continuous improvement of EM&S, driving end-to-end value creation projects across the total supply chain to deliver competitive advantage for the business.  
• Provides due diligence evaluation and advice on new sourcing and external manufacturing business opportunities in partnership with the Business Development (BD) team. Manages the integration and set up of new BD suppliers and represents Santen on external governance committees, such as Joint Manufacturing Committees.
• Negotiates and executes legal contracts, together with the Legal and BD teams, including Manufacturing & Supply Agreements and Technical Transfer Agreements, structuring such contracts in an optimal manner to ensure the security of long-term supply and the protection of the Santen business
• Performs other duties as necessary as assigned by management

<Education>

Essential
Degree in Life Sciences, Biological Sciences or Product Supply related areas. 

Desirable
Post-graduate training preferred (e.g. eMBA, finance training, engineering, lean 6 sigma etc.)

<Experience>

Essential

• Ten years plus experience in product supply and manufacturing in the pharmaceutical industry and/or the biologics industry
• Experience and solid track record in leading and managing external manufacturing suppliers in Asia
• Solid understanding of the drug development process, of GMP requirements and the manufacturing of sterile products.  Cell and gene therapy awareness an advantage
• Strong understanding of end-to-end supply chain management requirements
• Experience in a matrix organization, operating and communicating with senior level management, both internally and externally, and managing interdepartmental processes.
• Strong business acumen, and demonstrated improvements of business performance (optimization of cost, resources, results), as well as a sound understanding of relevant financial and legal aspects
• Experience in leading and managing in an international environment.

Desirable

• Experience with ERP/MRP systems

<Competencies/Skills>

• Ability to think critically and fast, to make both strategic and tactical decisions in design, management and execution of the sourcing and external manufacturing alliances
• Comfortable in a matrix organization, able to navigate political and cultural differences. Strong communication abilities and inter-personal skills.  Adept at working cross-functionally.
• Planning and prioritization
• Strong organizational development and change management skills
• Results focused and customer service orientated self-starter
• Strong management and leadership skills
• Proven track record of negotiating, both with internal stakeholders and with external partners
• Excellent writing, editing and computer skills including MS Office (Word, PowerPoint, Excel, Vision) and other planning and mapping tools
• Fluency in English (oral and written). Additionally able to communicate in either Chinese and/or Japanese

（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