Subject Matter Expert (SME) - Chemical API
- Birmingham
- Permanent
- Full-time
- To be a technology leader in nominated area(s) which includes:
- Being current in technical and subject knowledge
- Being aware of upcoming technology changes, developments, innovations
- Writing papers, presenting at industry conferences
- Being involved with industry bodies such as the ISPE, ICHEME (or equivalents)
- Promoting knowledge exchange within the company using appropriate forums, COPs, and teams
- To perform as an SME for the early project phases (i.e. ideally Site Master Planning, Feasibility, Concept and Basic Design phases). Typically this will include production and/or checking of early phase project deliverables appropriate to discipline speciality. This will include scoping and philosophy documents, production throughput analysis, process flow diagrams, equipment requirements, P&ID’s and layout philosophies, early phase project reports
- To technically assist project teams as required.
- To undertake Peer Reviews of work performed by other companies.
- To perform in appropriate SMEs reviews of client sites.
- To 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
- To participate and/or chair technical design reviews as appropriate.
- To support process risk assessments (HAZOP-LOPA, FMEA) in order to establish and deliver safe process operations and meet drug substance quality requirements.
- To actively support and participate in the PM Group’s R&D Team (TechTeam) and associated development and innovation activities.
- To support BD as required. This may include client visits, client pitches, proposal writing, and preparation of appropriate supporting materials.
- To be 80% bookable.
- Travel to Project meetings /workshops as required
- Other special projects as assigned
- Deep knowledge in the processes involved in the development, scale-up and commercial production of Chemical APIs
- Aspects related to unit operations such as Reactions, Separation Operations, Crystallisation, Gas based reactions. Filtration, Centrifugation, Drying, Milling and blending
- Principles of facility layout such as:
- Layout adjacencies
- Stack-up
- Segregation approaches
- Aspects related to technologies such as:
- Batch, semi-continuous and continuous processing
- Solvent and reagent handling
- Materials handling
- Cleaning technologies
- Solid, liquid and gaseous waste handling and treatment
- Automation
- Utility generation and distribution
- Aspects related to project delivery such as:
- Basis of design
- Safety framework including relief systems, ATEX, and containment
- Simulation tools
- Tech Transfer
- Bid analysis
- Supplier interfacing
- Commissioning and Qualification
- Aspects related to facility operations such as:
- Operating philosophies
- GMP Regulatory framework
- 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 an awareness of key industry technology initiatives and direction
- Excellent knowledge relating to area of speciality
- Direct experience working within capital projects and delivery related to process facility design and construction is essential.
- Good appreciation of appropriate Regulatory framework, such as FDA, EMA, ICH Guidelines