Job Description

Company DescriptionSanten 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 Formulation and Fill Finish Sciences & Technology Leader (FSTL) will be reporting to the Global Head of Manufacturing Sciences Analytics and Technology (MSAT) in the Global Product Supply (GPS) division.
• This role will be responsible for the leadership and delivery of business-critical projects by supporting all the pharmaceutical formulation and fill finish sciences and technology aspects related to late-stage and commercial Santen pharmaceutical products.
• The role will have the end-to-end ownership and accountability for the formulation and fill finish product 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.
• The role will also be accountable for driving the technology transfers of pharmaceutical formulation and fill finish 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 global project leaders and GPS senior management.
• The Candidate must have a demonstrated pharmaceutical chemistry and analytical expertise (i.e., solution, suspensions, and emulsions - ointments/cremes is a plus), strong project and budgeting management fundamentals, demonstrated leadership and exposure working in a global environment with a solid understanding of current global health authorities\' guidelines and requirements.
• The Formulation and Fill Finish Sciences & Technology Leader 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 formulation and fill finish sciences and technology evaluations, as well as lead when needed the handling and quick-turnaround complex investigations or projects.

Global Projects and Products Accountability

• Provide pharmaceutical formulation and fill finish sciences and technology leadership for programs, projects and activities related to Santen pharmaceutical product(s) to ensure business priorities and targets are met (e.g., New Product Introductions, product transfers, change management, regulatory submissions, etc.).
• Build and maintain the knowledge and history of the Santen pharmaceutical products formulation and fill finish (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.
• Lead to deliver the assets pharmaceutical formulation and fill finish needs, identification, and mitigation of manufacturing, analytics, and primary container closure systems properties 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

• Drive with the respective R&D and GPS functions, the global harmonization and standardization of procedures and methodologies for Santen product late-stage pharmaceutical formulation and fill finish development, primary container closure systems compatibilities, specifications and stability requirements, incl. applying and/or introducing PAT, DoE and QbD approaches (i.e., for API to Finished Product).
• Develop and establish the GPS formulation and fill finish sciences and technology and primary container closure systems selection 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 FSTL and Global MSAT organization.

Technology Transfers of Formulation and Fill Finish Processes

• Lead the pharmaceutical formulation and fill finish transfer teams of both sending and receiving sites (i.e., internal and/or external with CDMO counterparts) to successfully execute the implementation of all formulation and fill finish processes required for the project, by ensuring all planned activities, timelines, resources, and investments are assessed, planned, executed, and delivered in a timely manner and in budget.
• As a core member of the project leadership team, the FSTL will be reporting the formulation and fill finish processes transfer project progress to the assigned Global Project Lead.

Single GPS Point of Contact (SPOC) for Due Diligences

• The Formulation & Fill Finish Sciences & Technology Leader will support Due Diligence assessments of new in-licensing products and/or new assets acquisitions for all pharmaceutical formulation and fill finish sciences and technology evaluations.

Complex Investigations/Improvement Needs for Product(s)

• The Formulation & Fill Finish Sciences & Technology Leader will lead the assessments of complex pharmaceutical formulation and fill finish sciences and technology investigations or requirements for improvement of formulation processes and procedures for products, incompliance with current international guidelines, requirements and/or applicable registrations in Santen territories.
• She/he will derive the necessary root cause investigation approaches and mitigation strategies to ensure quick turnaround of faced challenges and paced product supply recovery.

Pharmaceutical Formulation Specific eCTD Sections Oversight

• Own Pharmaceutical Formulation & Fill Finish specific eCTD sections globally for the Santen pharmaceutical products to ensure consistency of content and compliance with all applicable international guidelines and requirements.

Training

• Own the Training Curriculum for her/his Job Profile and provide the necessary training and support to new associates joining this position.

Audit Support

• Maintain her/his work in a constant state of \xe2\x80\x9cinspection readiness\xe2\x80\x9d level and provide the necessary support in any internal or external audit.

Qualifications

• MSc. In Pharmacy, Pharmaceutical Technology, Chemistry, Biotech, Engineering, or equivalent scientific degree.
• Desirable PhD. or equivalent experience
• Fluent in English (minimum)
• Proficient in local language and other languages (desired)
• Minimum 10-15 years\' experience in pharmaceutical, chemical or biotechnology industry with strong formulation and fill finish processes development and lifecycle management background as formulation and fill finish development Group Head or Head of Operations, or similar
• Comprehensive know-how and expertise in pharmaceutical formulation and fill finish process, methods and technologies development for solutions, emulsions, suspensions is a must - additional experience and/or expertise in ointments / cremes a plus.
• Project Management and team leadership experience
• Solid understanding of managing budgets and resources (matrix-organization)
• Sound experience of data handling and applied statistics
• Fundamental understanding of international regulatory cGxP requirements across multiple health authorities (e.g., US, EU, JP) - China included.
• 5S / 6S Lean Six Sigma Certification

Additional InformationGrow your career at SantenA career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment. At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin/ancestry, religion, sexual orientation, gender, gender identity/ expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

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