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Job Description
**Bulk Bio SME Role Summary**: Technical leadership position providing expertise on Bulk Bio, working with global teams, and participating in industry bodies.
The Role We have an exciting opportunity for a Bulk Bio SME to join our team. As a Subject Matter Expert, you will provide technical leadership on Bulk Bio, working closely with global teams to deliver projects. **Key Responsibilities** * Provide technical leadership on Bulk Bio, staying current with technical and subject knowledge * Participate in industry bodies such as the ISPE, ICHEME, and Bio Phorum * Promote knowledge exchange within the company using appropriate forums, COPs, and teams * Perform as an SME for early project phases, including production and/or checking of deliverables * Technically assist project teams as required * Participate in Peer Reviews of work performed by other companies * Engage with global network of SMEs and assist in training and mentoring of next generation of Subject Matter Experts **Technical Expertise** * Upstream and downstream unit operations and support functions * Familiarity with equipment options and selection criteria * Principles of facility layout, including area classifications, layout adjacencies, and segregation approaches * Technologies such as process closure, connected and continuous processing, stainless steel and single-use systems, and bulk bio automation concepts * Facility operations, including operating philosophies, GMP regulatory framework, and project delivery **Qualifications** * Bachelor's degree; Masters preferred * 15 years+ of experience in design and/or operations and/or process development * History of wider industry engagement with institutions such as the ISPE * Excellent knowledge relating to area of speciality * Good understanding of principles of facility layout and design * Good appreciation of appropriate Regulatory framework * Good presentation skills and ability to client interface, facilitate workshops, and technically assist project teams **Why PM Group?** * As an employee-owned company, we are inclusive, committed, and driven * Corporate Responsibility and Sustainability are the heart of our new 2025 business strategy * Inclusion and Diversity are core to our culture and values * We commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents, and ideas