Bulk Bio Subject Matter Expert (SME) (Biotech)

Location: Hybrid, with the role based in a hirify.global office in Ireland, the UK, Belgium, the Netherlands, or Poland; travel to project meetings and workshops is required.

Company

hirify.global is an employee-owned international project delivery firm serving the pharmaceutical, food, medtech, and mission-critical sectors through offices in Europe, Asia, and the United States.

What you will do

• Provide technical leadership and subject matter expertise in bulk biopharmaceutical processing.
• Develop and review early-phase project deliverables, including scope and philosophy documents, throughput analyses, process flow diagrams, equipment requirements, P&IDs, layouts, and project reports.
• Support project teams with technical advice, peer reviews, client-site SME reviews, and technical design reviews.
• Contribute to industry engagement, technical papers, conferences, knowledge-sharing forums, R&D, innovation, and internal SME development.
• Support business development through client visits, pitches, proposal writing, and technical materials.
• Travel to project meetings and workshops as required.

Requirements

• Bachelor’s degree required; a master’s degree is preferred.
• At least 15 years of relevant experience in design, operations, or process development.
• Extensive knowledge of bulk bio unit operations, facility layout, equipment selection, process technologies, and facility operations.
• Understanding of GMP regulatory requirements, basis of design, basis of safety, simulation, technology transfer, commissioning, and qualification.
• Experience with modalities and expression systems such as mammalian, microbial, plant, and insect cells, blood fractionation, cell and gene therapy, RNA, oligonucleotides, peptides, ADCs, or vaccines.
• Strong presentation, problem-solving, innovation, client-interfacing, and workshop-facilitation skills, with industry engagement through bodies such as ISPE, IChemE, or BioPhorum.

Culture & Benefits

• Employee-owned organization with an inclusive culture focused on mutual respect and belonging.
• Work within a global network of more than 4,000 professionals.
• Participation in sustainability, corporate responsibility, R&D, and innovation initiatives.
• Reasonable accommodations are available during the recruitment process for candidates with disabilities.

Hiring process

• The recruitment process is designed to be fair and accessible.
• Reasonable accommodations can be requested during the recruitment process.