Senior Manager of Cell Line and Process Development - Remote

Overview

Oruka Therapeutics is seeking an experienced candidate to lead early-stage IND enabling cell line and cell culture process development and manufacturing activities, focusing on monoclonal antibodies.

In Short

• Lead cell line and process development for monoclonal antibodies.
• Oversee tech transfer and scale-up at CDMOs.
• Establish CMC strategy for early-stage development.
• Draft high-quality reports and regulatory submissions.
• Manage relationships with internal and external stakeholders.
• Apply QbD principles for process optimization.
• Support regulatory filings and compliance activities.
• Travel 20-25% for manufacturing activities.
• Work in a fast-paced environment.
• Contribute to a positive company culture.

Requirements

• Master’s or PhD in biochemistry, biotechnology, or related field.
• 8-10 years of experience in biologics programs.
• Experience with monoclonal antibodies and cell culture processes.
• Knowledge of CMC, quality, and regulatory aspects.
• Experience with tech transfers to CDMOs.
• Understanding of cGMP and FDA/EMA guidelines.
• Excellent writing and communication skills.
• Creative and strategic mindset.

Benefits

• Vibrant small-company culture.
• Competitive salary and benefits package.
• Opportunities for professional growth.