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 “inspection readiness” level and provide the necessary support in any internal or external audit.
