Global Head of Characterization BioAnalytics (Biopharma)

Location: Framingham, Massachusetts, United States; hybrid

Company

hirify.global is an R&D-driven, AI-powered biopharma company developing medicines and vaccines through immunoscience, data, and digital platforms.

What you will do

• Lead a new global characterization organization across multiple sites and countries.
• Develop and implement extended characterization strategies across antibodies, nanobodies, multispecifics, and viral and nonviral gene therapy modalities.
• Define critical quality attributes with alignment to analytical and integrated control strategies.
• Oversee resource allocation, budgeting, forecasting, project prioritization, and delivery across a complex biologics pipeline.
• Harmonize processes, advance analytical platforms, and maintain scientific and operational excellence across sites.
• Ensure high-quality analytical sections of CMC dossiers and transfer high-performance analytical methods to Manufacturing & Supply.

Requirements

• At least 15 years of industry experience, including at least 5 years leading an analytical characterization function.
• Broad experience in extended characterization of large molecules and strong knowledge of late-phase development.
• PhD in Analytical Chemistry, Molecular Biology, or an equivalent discipline.
• Strong understanding of CMC, biological drug development, process and formulation development, Quality by Design principles, and ICH guidelines.
• Experience with global NDA and MAA submissions, regulatory agency interactions, analytical project leadership, and method transfer.
• Fluent English required.

Nice to have

• Advanced scientific network in academia and industry.
• Track record of publications and patents.
• Familiarity with digitalization and the evolution of AI in CMC.

Culture & Benefits

• Opportunities for career growth through promotions, lateral moves, and international development.
• Health and wellbeing benefits, including healthcare, prevention, and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Patient-informed drug development and access to AI, data, and digital platforms.
• Supportive, future-focused environment within a global biopharma organization.