Teams at Formation Bio

Lead asset-level quality strategy by embedding Quality by Design, mapping risks/opportunities, conducting due diligence for in-licensed assets, driving audit-readiness for acquisition/commercial transitions, and applying global regulatory expectations (FDA/EMA/ICH) in AI-accelerated and digital environments.

Lead People operations, design and scale performance, promotion, compensation, and benefits programs, drive AI-native people systems and processes, partner with leaders on organizational strategy, manage vendors, and coach managers through complex people matters.

Lead GMP quality assurance for biologics programs, ensuring regulatory compliance, batch review and release, supplier/CDMO oversight, investigations, audits, quality agreements, and risk-based continuous improvement while exploring AI to enhance QA efficiency.