Subject Matter Expert
The role of a Subject Matter Expert (SME) is to provide technical leadership in the nominated area. This includes being current in technical and subject knowledge, aware of upcoming technology changes, developments, innovations, writing papers, presenting at industry conferences, involved with industry bodies, promoting knowledge exchange within the company using appropriate forums, COPs, and teams.
Key responsibilities include performing as an SME for early project phases, typically including production and/or checking of early phase project deliverables, scoping and philosophy documents, production throughput analysis, process flow diagrams, equipment requirements, P&ID's and layout philosophies, early phase project reports.
As an SME, you will technically assist project teams as required, undertake Peer Reviews of work performed by other companies, perform in appropriate SMEs reviews of client sites, engage with global network of SMEs and other staff, and assist in the training and mentoring of the next generation of Subject Matter Experts in the company.
Specific Knowledge Areas to be covered by the Role include Deep knowledge in the processes involved in the development, scale-up and commercial production of Chemical APIs.
In order to succeed in this role, you should have a Bachelor's degree; Masters preferred, Appropriate level of experience around Chemical API facility design and operations, A history of wider industry engagement with institutions such as the IChemE, ISPE (or equivalent), and awareness of key industry technology initiatives and direction.
Also, good appreciation of appropriate Regulatory framework, such as FDA, EMA, ICH Guidelines is essential.