Supports analytical development and characterization activities for late-stage biologic development leading to licensure application submission.
Takes a leading role in analytical characterization activities in support of comparability studies, heightened characterization studies, method development, control strategy development.
Supports preparation of regulatory submissions and regulatory engagement as technical subject matter expert as needed.
Akero Therapeutics, a Novo Nordisk company, is focused on discovering and developing transformational treatments for patients with serious metabolic diseases marked by high unmet need. They are a team of problem solvers dedicated to pursuing bold scientific approaches and have a collaborative spirit, breeding a culture where everyone feels inspired.