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Job Responsibilities:
- Operational oversight of analytical characterization activities within Akero.
- Develop and execute analytical heightened characterization studies and comparability assessments.
- Oversee phase-appropriate development, validation, and implementation of biologic analytical methods at CRO/CDMOs.
Qualifications:
- PhD and 5+ years of experience required.
- In-depth understanding of antibody structure and function and technical expertise in antibody characterization, release and stability testing.
- Experience in method development and method transfers into QC.
Experience:
- Experience/knowledge in cGMP, ICH and regulatory guidelines.
- Experience in authoring global regulatory filings.
- Knowledge of analytical methods used in in-process clinical drug substance and drug product manufacture.
Akero Therapeutics
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.