Role Overview:
- Provide technical and strategic leadership for late-stage CMC activities
- Work with internal and CDMO CMC teams to ensure timely delivery
- Partner closely with Program Management, Quality, Regulatory Affairs, CDMOs, and consultants.
Key Responsibilities:
- Oversee technical operations and lead strategy discussions for late-stage CMC activities
- Facilitate problem-solving, action planning, and decision-making within the CMC team
- Collaborate with manufacturing and clinical supply chain stakeholders to ensure robust clinical supply
Qualifications:
- Master’s or PhD in relevant disciplines with 10+ (MS) or 7+ (PhD) years of experience in biologics CMC functions
- Experience with pre-filled syringe and/or auto-injector is a plus
- Excellent writing, organization, communication and people management skills
Oruka Therapeutics
Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. They aim to offer patients suffering from chronic skin diseases the greatest possible freedom from their condition. The company seeks passionate individuals eager to contribute to an engaged, inclusive, and positive company culture.