Subject Matter Expert (SME) - Chemical API

As the Subject Matter Expert (SME) - Chemical API for the Group, you can be based from any of our Ireland, UK or Europe offices. Hybrid working in the role will require travel to project meetings/workshops as required.

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

• To be a technology leader in nominated area(s) which includes:

• Being current in technical and subject knowledge
• Being aware of upcoming technology changes, developments, innovations
• Writing papers, presenting at industry conferences
• Being involved with industry bodies such as the ISPE, ICHEME (or equivalents)
• Promoting knowledge exchange within the company using appropriate forums, COPs, and teams

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 adjacencies, Stack-up, Segregation approaches
• 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
• 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
• Aspects related to facility operations such as Operating philosophies, GMP Regulatory framework

Qualifications

• Bachelor’s degree; Masters preferred
• Appropriate level of experience around Chemical API facility design and operations
• A history of wider industry engagement with institutions such as the IChemE, ISPE (or equivalent) and an awareness of key industry technology initiatives and direction
• Excellent knowledge relating to area of speciality
• Direct experience working within capital projects and delivery related to process facility design and construction is essential.
• Good appreciation of appropriate Regulatory framework, such as FDA, EMA, ICH Guidelines

PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know.