Director, GMP Quality
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About The Position
Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria's pipeline includes our lead program, navenibart, a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema, as well as STAR-0310, an OX40 monoclonal antibody antagonist currently in preclinical development for atopic dermatitis (AD) and being explored for other allergic and immunological diseases. The Director of GMP Quality is responsible for overseeing and ensuring compliance with Good Manufacturing Practices (GMP) for biologics and combination products. This role involves leading GMP product quality assurance activities, ensuring that all products meet regulatory standards and company procedures and policies. The position also includes quality oversight of contracted manufacturers, laboratories, and clinical material supply for clinical products. The scope of this role covers globally manufactured and distributed products, ensuring compliance with FDA, EMA, and other applicable health authority requirements and regulations. The role requires close coordination with internal partners, including Pharmaceutical Sciences/Technical Operations, Clinical Operations, and Regulatory Affairs as well as developing and maintaining strong relationships with external partners.
