Chemical API Subject Matter Expert

Found in: Talent IE C2 - 2 weeks ago


Dublin, Ireland PM Group Full time

Responsibilities



To be a technology leader in nominated area(s) which includes:Being current in technical and subject knowledgeBeing aware of upcoming technology changes, developments, innovations Writing papers, presenting at industry conferencesBeing 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

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 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 adjacenciesStack-upSegregation approaches Aspects related to technologies such as: Batch, semi-continuous and continuous processingSolvent and reagent handlingMaterials handlingCleaning technologiesSolid, liquid and gaseous waste handling and treatmentAutomationUtility generation and distribution Aspects related to project delivery such as: Basis of designSafety framework including relief systems, ATEX, and containmentSimulation toolsTech TransferBid analysisSupplier interfacingCommissioning and Qualification Aspects related to facility operations such as: Operating philosophiesGMP Regulatory framework
Qualifications

Bachelor’s degree; Masters preferred 15 years+ of appropriate experience in design and/or operations and/or process development A history of wider industry engagement with institutions such as the ICHEME (or equivalent) and an awareness of key industry technology initiatives and direction Excellent knowledge relating to area of speciality A good understanding of the principles of facility layout and design as appropriate Good appreciation of appropriate Regulatory framework, such as FDA, EMA, ICH Guidelines
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