Head Of Product Science And Lab Operations (MSAT) (Director) (Cell And Gene Therapy)

TL;DR

Head Of Product Science And Lab Operations (Cell And Gene Therapy): Leading MSAT strategy and lab operations for emerging cell and gene therapy manufacturing with an accent on process science, technology transfer, and validation strategy. Focus on scaling advanced therapy platforms, optimizing COGS, and ensuring GMP compliance for clinical and commercial production.

Location: On-site in Hillsboro, Oregon, USA. Relocation is approved.

Salary: $151,600 - $281,500

Company

hirify.global, a member of the Roche group, is a pioneer in the biotechnology industry dedicated to discovering and developing transformative medicines for serious and life-threatening diseases.

What you will do

• Define and execute the MSAT strategy for cell therapy, aligning with site goals and the global Roche network.
• Lead process science, technology transfer, and validation strategies from development through commercial manufacturing.
• Oversee MSAT laboratory operations, including scale-down studies, material characterization, and closed-system modeling.
• Manage allogeneic donor operations, including laboratory activities and material qualification.
• Drive complex process troubleshooting and deviation investigations using root cause analysis and advanced data analytics.
• Collaborate with QA and Regulatory teams to support lifecycle activities, regulatory filings, and health authority inspections.

Requirements

• Bachelor's degree in Cell Biology, Molecular Biology, Biochemical Engineering or related field (12+ years exp) or Master's (8+ years exp).
• Minimum 3 years of experience in cell therapy manufacturing.
• 5+ years of experience leading technical teams and managing cross-functional stakeholders.
• Deep understanding of ATMPs, including autologous and allogeneic workflows, process control, and regulatory expectations.
• Proven track record of supporting regulatory submissions (e.g., IND, BLA) and health authority inspections.
• Experience with process monitoring and analytics tools such as JMP, Spotfire, or PI Historian.

Culture & Benefits

• Opportunity to shape and scale advanced therapy platforms in a state-of-the-art 75-acre facility.
• High-impact leadership role within a global network of scientific innovation.
• Culture focused on scientific rigor, GMP compliance, and continuous improvement.
• Comprehensive corporate benefits package and potential for a discretionary annual bonus.
• Collaborative environment emphasizing coaching, mentoring, and talent development.