Director, Manufacturing Sciences and TechnologyInsmed
THIS JOB HAS EXPIRED
Reporting to the Vice President of Technical Operations, in this newly created role the Director, MS&T will have responsibility for the oversight of manufacturing operations at our CMOs including process manufacturing and ensuring the continued refinement and enhancements of our existing manufacturing processes.
Responsible for the oversight of manufacturing operations at CMOs. This includes the introduction of appropriate process manufacturing engineering and technologies required to increase robustness and reproducibility of current manufacturing processes. This is to be achieved by leveraging the process expertise within Insmed and our contract partners and the definition and execution of appropriate DoE?s in Insmed?s pilot facility.
Additionally, as part of the company?s overall drive to improve manufacturing quality the Director will be responsible to develop KPI?s of department performance as measured by such metrics as success against manufacturing forecasts and manufacturing compliance (e.g. rapid resolution of manufacturing deviations and implementation of CAPA?s).
The Director will lead and manage a team of four direct reports.
Responsible to monitor the trend in CPP/KPP and batch release testing to ensure correction of adverse trends prior to loss of batches.
Experience in the design and operation of aseptic processing equipment.
10 years experience managing biological manufacturing processes (preferably of products marketed in the US and EU).
Experience using 6 sigma strategies to improve process performance.
5+ years experience leading teams tasked with implementation of manufacturing technology improvements within a regulated environment.
Has a successful track record working both with small-scale start-up companies as well as with multi-nationals
Experience working with CMOs is an advantage.
High energy, innovative ?can do? attitude is required
Bachelor?s degree in Chemical Engineering or equivalent is required. Advanced degree is preferred.