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Bulk Bio Subject Matter Expert (SME)
Pm Group
Global engineering, architecture, and project management consultancy.
Lead technical SME for bulk bioprocessing, guiding design and delivery
Being involved with industry bodies such as the ISPE, ICHEME, BioPhorum
Travel to Project meetings /workshops as required
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 undertake Peer Reviews of work performed by other companies.
To participate and/or chair technical design reviews as appropriate
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 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 support BD as required. This may include client visits, client pitches, proposal writing, and preparation of appropriate supporting materials.
Writing papers, presenting at industry conferences
To technically assist project teams as required.
What you bring
regulatory
simulation
facility layout
15+ years
bachelor's
masters
Good appreciation of appropriate Regulatory framework
Good presentation skills and be comfortable client interfacing, facilitating workshops and technically assisting project teams.
Principles of facility layout such as:
Being current in technical and subject knowledge
Simulation tools
Excellent knowledge relating to area of speciality
Upstream and downstream unit operations and support functions, as well as familiarity of equipment options available and the selection criteria as to when such options should be chosen.
Bulk bio automation concepts
A good understanding of the principles of facility layout and design as appropriate
Have the ability to distil down problems to their essence, demonstrate problem solving ability, and have an ability to innovate.
15 years+ of appropriate experience in design and/or operations and/or process development
Connected and continuous processing
Being aware of upcoming technology changes, developments, innovations
Bachelor’s degree; Masters preferred
Good experience of various modalities and expression systems which may include: Mammalian cells, microbial systems, plant cells, insect cells, blood fractionation, CGT, RNA, Oligonucleotides, Peptides, ADCs, Vaccines
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