[global] Director, Chemical Sciences

vor 3 Monaten

Genf GE, Schweiz Santen Vollzeit

**Company Description** 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.**

**PURPOSE OF ROLE**
- The Chemical Sciences & Technology Leader (CSTL) will be reporting to the Global Head of Manufacturing Sciences Analytics and Technology (MSAT) in the Global Product Supply (GPS) division.
- The role will be responsible for the leadership and delivery of business-critical projects by supporting all the chemical sciences and technology aspects related to late-stage and commercial Santen pharmaceutical products.
- As CSTL, this role will have the end-to-end ownership and accountability for the chemical sciences & technology of active pharmaceutical ingredients (API), intermediates, excipients and/or starting materials for the Santen product(s) strategy, taking accountability from the R&D for the Phase III / commercial readiness development to the completed implementation of PPQ process performance, qualification, and throughout the products lifecycle management, in the supplied territories.
- This role will also be accountable for driving the technology transfers of active pharmaceutical ingredients (API), intermediates, excipients and/or starting materials globally, setting up and leading sending and receiving site teams, designing, and planning studies and activities with the respective cross-functional partners (e.g., with internal / external partnering site functions), executing all studies and activities, managing the project timelines and deliverables, assigned resources, budget and reporting the project progression to the Global Project Leader and GPS senior management.
- The CSTL is an expert and skilled chemist with strong physical-chemistry analytical background, proficient in project and budgeting management fundamentals, demonstrated leadership and exposure working in a global environment fulfilling all current global health authorities’ guidelines and requirements.
- The role will additionally support Due Diligence assessments of new in-licensing products and/or new assets acquisitions, as the GPS single point of contact for all chemical sciences and technology evaluations, as well as lead when needed the handling and quick-turnaround complex investigations or projects.

**Job Description** Global Projects and Products Accountability**
- Provide chemical sciences and technology leadership for programs, projects and activities related to Santen pharmaceutical product(s) development and commercial supply to ensure business priorities and targets are met (e.g., New Product Introductions, product transfers, change management, regulatory submissions, etc.).
- Build and maintain the chemical sciences and technology knowledge and history of the Santen pharmaceutical products (i.e., for API to Finished Product) from late-stage development (i.e., readiness for Phase III) throughout the commercial lifecycle, working in close collaboration with the respective Global R&D, MSAT and wider Product Supply functional teams.
- Drive chemical sciences and technology specific projects aimed at enabling cost improvements and business continuity risk reductions (e.g., second sourcing), through the mapping, assessment, and improvement of the Santen GPS supplier network for active pharmaceutical ingredients (API), intermediates, excipients and/or starting materials.
- Lead to deliver the assets chemical sciences and technology needs, identification, and mitigation of manufacturing, analytics and other related supply and business continuity risks, as well as drive process characterization studies and strategies to support post-approval changes for the accountable product(s).
- Create and establish best practices, knowledge sharing platforms with cross-functional and cross-divisional teams across the business (e.g., R&D, MSAT, QA, SC, Regulatory and Project Management) to ensure all Santen pharmaceutical products are maintained in compliance with current international guidelines and requirements.

**Global MSAT Accountability**
- Develop and establish the GPS chemical sciences and technology decision gates for the development of late-stage product readiness confirmation to enable sustainable and reliable phase III clinical material manufacture and future commercial supply.
- Contribute to the drafting, review and/or approval of current and new (internal) global and/or local standard operating procedures and guidelines, related to the new roles and responsibilities of the CSTL and Global MSAT organization.

**Technology Transfers of Chemical Manufacturing Processes**
- Lead the chemical sciences and technology transfer teams of both sending and receiving sites (i.e., internal and/or external with CDMO counterparts) to succ

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