Associate Director, Downstream, Manufacturing Sciences and Technology (Biologics)late

Oruka Therapeutics is seeking an Associate Director, Downstream, Manufacturing Sciences and Technology (Biologics) to lead downstream late-stage and pivotal enabling optimization, scale-up and transfer of manufacturing activities. The ideal candidate will be responsible for process development, troubleshooting production issues, data analysis, and ensuring compliance with regulatory standards to maintain product quality.

Requirements

• Master’s or a PhD degree in biochemistry, biochemical engineering, biotechnology or equivalent
• At least 8 years of relevant experience developing, scaleup, and transfer of downstream processes for biologics
• Significant experience managing manufacturing in an MSAT environment
• Direct hands-on experience with monoclonal antibodies is a plus
• Expertise in purification process optimization with an emphasis on scale-up, scale-down models, process robustness, facility fit and overall commercial readiness
• In depth knowledge of CMC, quality and compliance, as well as regulatory aspects of biopharmaceutical development and life-cycle management
• Demonstrated track record of successful tech transfers to CDMOs with an eye towards late stage and commercial process development
• Direct experience or exposure to transition of processes from early stage to late stages such as process characterization, FMEA and PPQ campaigns, with emphasis on phase appropriate control strategy
• Direct experience in design-of-experiments (DoE) and robust data analysis via industry standard statistical tools

Benefits

• Competitive salary and benefits package
• A supportive and inclusive team environment
• Opportunities for professional growth and development