Job Purpose
The Senior Technical Manager, Device will act as the subject matter expert responsible for all activities related to the development and PPQ (process performance qualification) for assembly of drug device combination product (DDC), functional testing of DDC to supply clinical studies and launch / commercial phase, as well as review and update the dossier in support of the required submissions for clinical use and commercial launch.
Main Accountabilities:
Main Accountabilities:
- Act as Technical Subject Matter Expert for DDC related topics
- Act as a Project leader to define and drive technical deliverables and ensure timely delivery of GMP DDC product batches
- Manage the creation and review of relevant device design documents required for the Design History File and General Safety Performance Requirements for each presentation of the DDC product (autoinjector, needle safety device)
- Ensure a successful Human Factor study for each presentation of the DDC product (autoinjector, needle safety device)
- Ensure strong relationship and efficient collaboration with CMOs
- Ensure PPQ is successfully achieved and ready for commercial launch
- Review and/or approve batch documentation, validation related activities, risk/gap analysis, protocols and reports
- Manage stability plan and review of data to support product shelf-life and extreme conditions
- Support technical decision making, trend analysis, and root cause investigations within a timely manner to avoid potential delays and/or interruption to supply
- Support quality, supply, innovation and cost aspects for DDC
- Support the DDC regulatory submissions and responses to Health Authority questions / requests
- Effectively partner with internal stakeholders to support drug product production, clinical development, product supply / transport activities
- Support and/or contribute to intellectual property strategy and filings where DDC subject matter expertise is needed