Join to apply for the Bulk Bio Subject Matter Expert (SME) role at PM Group
We have an exciting opportunity for a Bulk Bio SME to join our team. The role involves providing technical leadership on Bulk Bio as a Subject Matter Expert. The employed candidate can be located in Ireland, UK, Belgium, The Netherlands, or Poland, working a hybrid model with travel to project meetings/workshops as needed.
About PM Group
PM Group is an employee-owned, international project delivery firm with over 3,800 employees, leading in pharma, food, medtech, and mission-critical sectors across Europe, Asia, and the US. We focus on sustainable growth centered around our people, clients, and partners.
Responsibilities
1. Lead in nominated technology areas, staying current with industry knowledge, innovations, and participating in industry bodies like ISPE, ICHEME, BioPhorum.
2. Perform as an SME during early project phases, including site master planning, feasibility, and conceptual design, producing relevant project deliverables.
3. Assist project teams technically and undertake peer reviews of work by other companies.
4. Review client sites as an SME and engage with global SME networks for training and mentorship.
5. Participate in technical design reviews and support R&D activities.
6. Support business development efforts, including client visits, pitches, and proposals.
7. Travel to project meetings/workshops as required.
8. Handle other special projects as assigned.
Knowledge Areas
* Upstream/downstream unit operations, equipment options, and facility layout principles.
* Technologies such as process closure, continuous processing, stainless and single-use systems, automation, CIP/SIP, utilities, and waste systems.
* Facility operations including GMP and regulatory frameworks.
* Project delivery aspects like basis of design, safety, simulation, tech transfer, commissioning, and qualification.
* Experience with modalities such as mammalian, microbial, plant, insect cells, blood fractionation, CGT, RNA, oligonucleotides, peptides, ADCs, vaccines.
Qualifications
* Bachelor’s degree; Master’s preferred.
* 15+ years of experience in design, operations, or process development.
* Industry engagement with institutions like ISPE and awareness of industry initiatives.
* Strong knowledge in the specialty area, facility layout, and regulatory principles.
* Excellent presentation and client interfacing skills, problem-solving, and innovation ability.
Why Join PM Group?
As an employee-owned company, we promote inclusion, sustainability, and diversity, fostering a culture of mutual respect and belonging. We are committed to fair hiring practices and providing accommodations for candidates with disabilities.
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