Biopharmaceutical Process Development Leader
6 days ago
Oruka Therapeutics is seeking an experienced Biopharmaceutical Process Development Leader to join our team. In this role, you will be responsible for leading the development and manufacturing of biologics for clinical and commercial use.
About Oruka TherapeuticsWe are a cutting-edge biotechnology company developing novel biologics for the treatment of chronic skin diseases. Our mission is to offer patients suffering from these conditions the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year.
Job Description- Manage purification development and manufacturing operations at Contract Development and Manufacturing Organizations (CDMOs) for multiple programs.
- Work with CDMOs to optimize purification unit operations, emphasizing robustness, scalability, quality, cost, validation, and commercial readiness.
- Build strong relationships and partnerships with other leaders across Development, Quality, Regulatory, and external CDMOs.
- Lead purification manufacturing campaigns and timelines, ensuring seamless execution, timely completion, and handoff to the drug product team.
- Masters or PhD degree in biochemistry, biochemical engineering, biotechnology, or equivalent with 8-10 years of relevant experience working with biologics programs in clinical development.
- Significant experience developing purification processes in support of biologics manufacturing for clinical/commercial use, with direct experience with monoclonal antibodies.
- Expertise in purification process optimization, scale-up, scale-down models, process monitoring, facility fit, and commercial readiness.
- In-depth knowledge of Current Good Manufacturing Practice (cGMP), ICH, WHO, and FDA/EMA guidelines, and experience utilizing them in a phase-appropriate manner.
- Excellent writing, organization, communication, and people management skills, with the ability to work effectively with diverse internal and external stakeholders.
The estimated salary for this position is $120,000 - $180,000 per year, depending on experience. Oruka Therapeutics offers a competitive benefits package, opportunities for professional growth and development, and a chance to make a real impact every day.
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