Bulk Bio Subject Matter Expert (SME)

PM Group; Birmingham; Hybrid; GBP 75,000 - 95,000; Full time

Job summary

An employee-owned engineering firm in Birmingham seeks a Bulk Bio SME to provide technical leadership. This role involves engaging with project teams, mentoring future SMEs, and participating in industry events. A Bachelor's degree and 15+ years of relevant experience are required. The firm promotes an inclusive culture and supports corporate responsibility initiatives.

Qualifications

• 15+ years of relevant experience in design, operations, or process development.
• Experience engaging with industry institutions like ISPE.
• Good understanding of regulatory frameworks and facility design.

Responsibilities

• Act as a technology leader in nominated areas.
• Serve as an SME for early project phases.
• Assist project teams and engage with the global network of SMEs.

Skills

Upstream and downstream unit operations

Facility layout principles

Excellent presentation skills

Strong problem solving capability

Education

Bachelor’s degree

Master’s degree preferred

Job description

PM Group Birmingham, England, United Kingdom

Overview

We have an exciting opportunity for a Bulk Bio SME to join our team. The role is to work as a Subject Matter Expert providing technical leadership on Bulk Bio. As a member of the global SME Group the person employed can be located in one of the PM Group offices in Ireland, UK, Belgium, The Netherlands or Poland. We work a hybrid work model while the role will require travel to project meetings/workshops as required.

Responsibilities

• Be a technology leader in nominated area(s) including:
  • Keeping current in technical and subject knowledge
  • Being aware of upcoming technology changes, developments, and innovations
  • Writing papers and presenting at industry conferences
  • Engaging with industry bodies such as ISPE, ICHEM, BioPhorum
  • Promoting knowledge exchange within the company using appropriate forums, COPs, and teams
• Serve as an SME for early project phases (Site Master Planning, Feasibility, Concept and Basic Design). This includes production and/or checking of early phase deliverables such as scoping and philosophy documents, production throughput analysis, process flow diagrams, equipment requirements, P&IDs and layout philosophies, and early phase project reports
• Technically assist project teams as required
• Undertake peer reviews of work performed by other companies
• Perform in appropriate SME reviews of client sites
• Engage with the global network of SMEs and staff; assist in training and mentoring the next generation of SMEs
• Participate and/or chair technical design reviews as appropriate
• Support PM Group’s R&D Team (TechTeam) and related development activities
• Support business development as required (client visits, pitches, proposal writing, and preparation of supporting materials)
• Travel to project meetings/workshops as required
• Other special projects as assigned

Specific Knowledge Areas

• Upstream and downstream unit operations and familiarity with equipment options and selection criteria
• Facility layout principles including area classifications, layout adjacencies, and segregation approaches
• Technologies such as process closure, connected and continuous processing, stainless steel and single-use systems, bulk bio automation, CIP/SIP, clean utility generation and distribution, and waste systems
• Facility operations aspects including operating philosophies and GMP regulatory framework
• Project delivery aspects such as basis of design, basis of safety, simulation tools, tech transfer, commissioning and qualification
• Experience with multiple modalities and expression systems (e.g., mammalian, microbial, plant, insect; CGT, RNA, oligonucleotides, peptides, ADCs, vaccines)

Qualifications

• Bachelor’s degree; Master’s degree preferred
• 15+ years of relevant experience in design and/or operations and/or process development
• Experience engaging with industry institutions (e.g., ISPE) and awareness of key industry technology initiatives
• Excellent knowledge relating to area of specialty
• Good understanding of facility layout and design principles
• Good appreciation of regulatory framework
• Good presentation skills; comfortable client interfacing, facilitating workshops, and assisting project teams
• Ability to distill problems to their essence, strong problem solving and innovation capability

Why PM Group?

PM Group is an employee-owned company with a diverse, inclusive culture. We are focused on corporate responsibility and sustainability as part of our 2025 strategy. We are committed to a fair and accessible hiring process and provide reasonable accommodations as needed to participate in recruitment.

Seniorities

• Seniority level: Not Applicable
• Employment type: Full-time

Job function & Industry

• Job function: Science, Consulting, and Project Management
• Industries: Construction and Design Services

Notes: This description excludes irrelevant boilerplate and recruitment prompts. It retains the core role, responsibilities, qualifications, and company context.