Subject Matter Expert (SME) - Chemical API

Description

• 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
• Travel to Project meetings /workshops as required
• 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.
• Promoting knowledge exchange within the company using appropriate forums, COPs, and teams
• 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 perform in appropriate SMEs reviews of client sites.
• To undertake Peer Reviews of work performed by other companies.
• Being involved with industry bodies such as the ISPE, ICHEME (or equivalents)
• Writing papers, presenting at industry conferences
• To technically assist project teams as required.
• To support BD as required. This may include client visits, client pitches, proposal writing, and preparation of appropriate supporting materials.
• To participate and/or chair technical design reviews as appropriate.

Requirements

• Safety framework including relief systems, ATEX, and containment
• Bid analysis
• Being aware of upcoming technology changes, developments, innovations
• Deep knowledge in the processes involved in the development, scale-up and commercial production of Chemical APIs
• Principles of facility layout such as:
• Being current in technical and subject knowledge
• Direct experience working within capital projects and delivery related to process facility design and construction is essential.
• Aspects related to unit operations such as Reactions, Separation Operations, Crystallisation, Gas based reactions. Filtration, Centrifugation, Drying, Milling and blending
• Batch, semi-continuous and continuous processing
• Bachelor’s degree; Masters preferred
• Excellent knowledge relating to area of speciality
• Solvent and reagent handling
• Appropriate level of experience around Chemical API facility design and operations
• Good appreciation of appropriate Regulatory framework, such as FDA, EMA, ICH Guidelines
• Simulation tools

Benefits

• Tech Transfer
• To be 80% bookable.

Training + Development

Interview process

Visa Sponsorship

Security clearance