Subject Matter Expert - 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. This role involves hybrid working, which will require travel to project meetings and workshops as needed.

Responsibilities

1. Technology Leadership: Be a leader in nominated areas, staying current with technical and subject knowledge, industry developments, and innovations. Engage in writing papers, presenting at industry conferences, and participating in industry bodies such as ISPE, ICHEME, or equivalents. Promote knowledge exchange within the company through forums, COPs, and teams.
2. Subject Matter Expert Duties: Act as SME during early project phases (Site Master Planning, Feasibility, Concept, and Basic Design). This includes producing and reviewing project deliverables like scope and philosophy documents, throughput analysis, process flow diagrams, equipment requirements, P&ID’s, and layout philosophies.
3. Training and Mentoring: Collaborate with the global network of SMEs and staff, assisting in training and mentoring the next generation of SMEs within the company.
4. Technical Reviews and Support: Participate in or chair technical design reviews, support process risk assessments (HAZOP, LOPA, FMEA), and contribute to safe process operations that meet drug substance quality standards.
5. Research and Development: Actively support PM Group’s R&D team (TechTeam) and related innovation activities.
6. Business Development: Support business development activities, including client visits, pitches, proposal writing, and preparing supporting materials.

Knowledge Areas

• Deep knowledge of Chemical API development, scale-up, and production processes.
• Understanding of unit operations such as reactions, separation, crystallization, gas reactions, filtration, centrifugation, drying, milling, and blending.
• Facility layout principles, including adjacency, stack-up, and segregation.
• Technologies like batch, semi-continuous, and continuous processing; solvent and reagent handling; automation; waste treatment; utility systems.
• Project delivery aspects including Basis of Design, safety frameworks, simulation tools, tech transfer, bid analysis, supplier interfacing, commissioning, and qualification.
• Facility operations knowledge including operating philosophies and GMP/regulatory requirements.

Requirements

• Bachelor’s degree; Master’s preferred.
• Relevant experience in Chemical API facility design and operations.
• Engagement with industry institutions such as IChemE, ISPE, and awareness of key industry initiatives.
• Excellent knowledge of the specialty area.
• Experience with capital projects related to process facility design and construction.
• Understanding of regulatory frameworks like FDA, EMA, ICH guidelines.

Why PM Group? As an employee-owned company, we are inclusive, committed, and driven. We prioritize corporate responsibility and sustainability as part of our 2025 business strategy.

We value inclusion and diversity, fostering a culture of mutual respect and belonging. We are committed to fair hiring practices and providing accommodations for candidates with disabilities.

If you need assistance, please let us know.