Global Head of Characterization, BioAnalytics

Location: Framingham, Massachusetts, United States; hybrid. The role is available to US and Puerto Rico residents.

Salary: $232,500–$335,833 per year.

Company

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

What you will do

• Lead a new global organization across multiple sites and countries, reporting to the Global Head of BioAnalytics, CMC Development.
• Develop and implement characterization strategy across antibodies, nanobodies, multispecifics, and viral and nonviral gene therapy modalities.
• Direct resource allocation, budgeting, forecasting, operations, and project deliverables across a complex biologics pipeline.
• Define CQAs with alignment to analytical and integrated control strategies during CMC development.
• Partner with BioAnalytics and CMC leadership to prioritize work and ensure timely delivery.
• Harmonize processes, advance analytical platforms, support CMC dossiers, and transfer high-performance analytical methods.

Requirements

• At least 15 years of industry experience, including at least 5 years leading an analytical characterization function.
• Broad, long-term experience in extended characterization of large molecules and late-phase development.
• PhD in Analytical Chemistry, Molecular Biology, or an equivalent qualification.
• Strong understanding of CMC, process and formulation development, Quality by Design principles, and ICH guidelines.
• Experience with global NDA and MAA submissions, regulatory approvals, and agency interactions.
• Fluent English and the ability to lead large, global, highly scientific teams.

Nice to have

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

Culture & Benefits

• Supportive, future-focused environment with opportunities for promotion and international career development.
• Health, wellbeing, prevention, and wellness benefits.
• At least 14 weeks of gender-neutral parental leave.
• Work with AI, data, and digital platforms at the forefront of drug discovery.
• Employee compensation and benefit programs.