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Chemical API Subject Matter Expert (SME), Cork
Client: PM Group
Location: Cork, Ireland
Job Category: Other
EU work permit required: Yes
Job Reference: 21f8417d7785
Job Views: 2
Posted: 02.04.2025
Expiry Date: 17.05.2025
Job Description:
Overview
The Role: We have an exciting opportunity for a Chemical API SME to join our team. The role is to work as a Subject Matter Expert providing technical leadership on Chemical API. As a member of the global SME Group, the person employed can be located in one of the PM Group offices in Europe. We work a hybrid work model while the role will require travel to project meetings/workshops as required.
Who we are: PM Group is an employee-owned, international project delivery firm with a team of 3,500+ people. We are world leaders in the pharma, food, medtech, and mission-critical sectors. From our network of offices in Europe, Asia, and the US, we work with the world's leading organisations. We are focused on growing a sustainable business centred around our people, our clients, and trade partners.
Responsibilities
1. To be a technology leader in nominated area(s) which includes:
1. Being current in technical and subject knowledge
2. Being aware of upcoming technology changes, developments, innovations
3. Writing papers, presenting at industry conferences
4. Being involved with industry bodies such as the ISPE, ICHEME (or equivalents)
5. Promoting knowledge exchange within the company using appropriate forums, COPs, and teams
2. 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 specialty.
3. To technically assist project teams as required.
4. To undertake Peer Reviews of work performed by other companies.
5. To perform in appropriate SMEs reviews of client sites.
6. 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.
7. To participate and/or chair technical design reviews as appropriate.
8. To support process risk assessments (HAZOP-LOPA, FMEA) in order to establish and deliver safe process operations and meet drug substance quality requirements.
9. To actively support and participate in the PM Group’s R&D Team (TechTeam) and associated development and innovation activities.
10. To support BD as required. This may include client visits, client pitches, proposal writing, and preparation of appropriate supporting materials.
11. To be 80% bookable. Travel to Project meetings/workshops as required.
12. Other special projects as assigned.
Specific Knowledge Areas to be covered by the Role include:
1. Deep knowledge in the processes involved in the development, scale-up, and commercial production of Chemical APIs
2. Aspects related to unit operations such as Reactions, Separation Operations, Crystallisation, Gas-based reactions, Filtration, Centrifugation, Drying, Milling, and blending
3. Principles of facility layout such as Layout adjacencies, Stack-up, Segregation approaches
4. Aspects related to technologies such as Batch, semi-continuous and continuous processing, Solvent and reagent handling, Materials handling, Cleaning technologies, Solid, liquid and gaseous waste handling and treatment, Automation, Utility generation and distribution
5. Aspects related to project delivery such as Basis of design, Safety framework including relief systems, ATEX, and containment, Simulation tools, Tech Transfer, Bid analysis, Supplier interfacing, Commissioning and Qualification
6. Aspects related to facility operations such as Operating philosophies, GMP, Regulatory framework
Qualifications
1. Bachelor’s degree; Masters preferred
2. 15 years + of appropriate experience around Chemical API facilities and operations
3. A history of wider industry engagement with institutions such as the ICHEME (or equivalent) and an awareness of key industry technology initiatives and direction
4. Excellent knowledge relating to area of speciality
5. Direct experience working within capital projects and delivery related to process facility design and construction
6. Good appreciation of appropriate Regulatory framework, such as FDA, EMA, ICH Guidelines
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