Chemical API Subject Matter Expert (SME) > PM Group > Joboolo BE :
Société : PM Group Lieu : Antwerpen Flanders Site source : Talent BE
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 reportsTo 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 SubjectMatterExperts in the companyTo 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 requiredOther special projects as assigned Specific Knowledge Areas to be covered by the Role includeDeep knowledge in the processes involved in the development, scale-up and commercial production of Chemical APIsAspects 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 approachesAspects 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 QualificationAspects 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 developmentA history of wider industry engagement with institutions such as the ICHEME (or equivalent) and an awareness of key industry technology initiatives and directionExcellent knowledge relating to area of specialityA good understanding of the principles of facility layout and design as appropriateGood appreciation of appropriate Regulatory framework, such as FDA, EMA, ICH Guidelines PM Group AntwerpenFlanders
