Jobs at Oruka Therapeutics

Provide administrative and office operations support including executive calendar management, travel and expense processing, PO and vendor coordination, meeting logistics, document management, onboarding logistics, and cross-functional project support for R&D and clinical teams.

Manage operational lifecycle of clinical trial biospecimens, coordinate vendors and central/specialty labs, ensure chain-of-custody and data reconciliation, track inventories, support audits and SOPs, and help develop scalable biosample processes and reporting.

Lead GMP quality oversight for Oruka's biologics development and external manufacturing partners (CDMOs). Ensure compliance with cGMP/FDA/EMA/ICH/WHO, manage QMS activities, review and approve GMP documentation, investigations, change controls, CAPAs, lot disposition, labeling, inspection readiness, and contribute to regulatory submissions. Travel ~15–20% to suppliers and sites.

Lead QC strategy and operations for late-stage biologics and combination products. Oversee analytical method validation, transfers, stability, release, PPQ support, vendor/CMO governance, investigations, data integrity, regulatory submissions, and inspection readiness to enable BLA/commercial launch.

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.

The Accounting Manager oversees accrual processes for clinical trials, collaborates with teams for data analysis, prepares journal entries, and ensures compliance with accounting standards and internal controls.

The Senior Paralegal/Senior Contracts Manager will manage the contracts lifecycle, support legal matters, and maintain corporate records for a biopharma company, ensuring compliance and effective legal operations.

The Director of Biostatistics will lead statistical strategy for clinical development programs, design studies, and provide statistical input for regulatory submissions while collaborating across teams.