About this role
Associate Director/Director, Analytical Development and Validation, Tech Ops (Biologics) at Oruka Therapeutics. Location: Waltham or United States. Role: Lead analytical development, Oversee validation and transfer, Coordinate regulatory interactions Requirements: Senior role leading analytical development/validation for biologics; requires MSc/PhD with 7+ or 5+ years respectively; experience in monoclonal antibodies, PFS/Auto Injectors, regulatory filings; able to lead teams and manage CDMOs. Category: Research and Development (R&D) Seniority: Senior Level Tools: U/HPLC, Capillary Electrophoresis, Spectrophotometer, Bioassay (ELISA and Cell-Based), ISO device testing, ICH guidelines Commitment: Full Time Workplace: Hybrid Languages: English