Associate Director/Director, Analytical Development and Validation, Tech Ops (Biologics)

Oruka Therapeutics is seeking an Associate Director/Director of Analytical Development and Validation to lead late-stage analytical activities for biologics, including method validation and comparability efforts. The ideal candidate has expertise in analytical method validation, device functional testing, and regulatory expectations for late-stage biologics, with a focus on monoclonal antibodies.

Requirements

• Lead late-stage analytical development activities for biologics
• Provide subject matter expertise for ICH Q2/Q14, USP/EP/JP, and global regulatory expectations
• Oversee validation of assays including potency/bioassays, purity and impurities, identity, characterization, residuals, and device functional testing
• Drive analytical strategies to support BLA/MAA submissions, post-approval changes, and comparability studies
• Partner with Process Development, Manufacturing, Quality, and Regulatory to support late-stage development, tech transfer, and commercial launch readiness

Benefits

• Competitive salary and benefits package
• A supportive and inclusive team environment
• Opportunities for professional growth and development
• A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients