Publicada el 18 junio
Misión del puesto
Experteer Overview In this role you will own the external manufacturing lifecycle for defined FDFs and APIs, focusing on transfer, validation, and lifecycle management across CMOs. You will drive gap analyses, material evaluations, and change control to ensure compliant, scalable manufacturing. You will coordinate cross-functional teams (QA, QC, Regulatory, CMO partners) to deliver TT projects and continuous process improvements. You will work in a fast-growing CNS-focused environment with a strong emphasis on collaboration, data-driven decisions, and regulatory readiness. This is a pivotal position shaping how we transfer and optimize manufacturing for CNS products at a European scale.Compensaciones / Ventajas
- Review and support manufacturing process validation protocols and reports from CMOs
- Conduct gap analyses across manufacturing processes, raw materials, and packaging materials between CMOs
- Define and implement TT/transfer strategies and validation plans for FDFs
- Coordinate material approvals (starting materials, packaging) for validation batches
- Prepare and maintain technical reports and SOPs; support regulatory and QA activities
- Provide technical support to CMOs and internal teams; monitor project milestones and deliverables
- Lead cross-departmental relationships to address gaps and drive improvements
- Serve as Project Manager for TT projects, tracking timelines, costs, risks, and changesResponsabilidades
- Experience 1-2 years in technology transfer in External manufacturing
- Extensive knowledge of manufacturing processes for pharmaceutical products (FDFs)
- Familiarity with GMP, Change Control procedures, and regulatory supports
- Willingness to travel to support CMOsRequisitos principales
- Individual Professional development
- Attractive remuneration
- Inspiring leadership
- Inclusive culture promoting diversity
