Teams at Oruka Therapeutics

The Associate Director, CMC Lead will provide strategic leadership for CMC activities in biologics, oversee technical operations, collaborate with internal teams and CDMOs, and ensure successful regulatory submissions.

This role involves leading device development for prefilled syringes and auto-injectors, integrating medical engineering and human-centered design, and ensuring compliance with regulatory standards throughout the product lifecycle.

The role oversees QA for clinical supply chain activities including compliance, oversight of IRT systems, labeling, distribution, and cold chain management supporting Phase 2 and Phase 3 programs.