Bulk Bio Subject Matter Expert (SME)

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 perform in appropriate SMEs reviews of client sites
• 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 participate and/or chair technical design reviews as appropriate
• Writing papers, presenting at industry conferences
• To support BD as required. This may include client visits, client pitches, proposal writing, and preparation of appropriate supporting materials
• To actively support and participate in the PM Group’s R&D Team (TechTeam) and associated development and innovation activities
• To undertake Peer Reviews of work performed by other companies
• To technically assist project teams as required
• Being involved with industry bodies such as the ISPE, ICHEME, BioPhorum

Requirements

• Being aware of upcoming technology changes, developments, innovations
• Good presentation skills and be comfortable client interfacing, facilitating workshops and technically assisting project teams.
• A good understanding of the principles of facility layout and design as appropriate
• Principles of facility layout such as:
• Connected and continuous processing
• Being current in technical and subject knowledge
• Good appreciation of appropriate Regulatory framework
• 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
• 15 years+ of appropriate experience in design and/or operations and/or process development
• Bachelor’s degree; Masters preferred
• Excellent knowledge relating to area of speciality
• Have the ability to distil down problems to their essence, demonstrate problem solving ability, and have an ability to innovate.
• 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
• Simulation tools

Benefits

• Tech Transfer
• Clean utility generation and distribution

Training + Development

Interview process

Visa Sponsorship

Security clearance