Principal Scientist, CMC Analytical Development

Akero Therapeutics, a Novo Nordisk company, is seeking a Principal Scientist for CMC Analytical Development. The successful candidate will support analytical development and characterization activities for late-stage biologic development, working closely with cross-functional teams to develop CQA risk assessments and mitigation strategies.

Requirements

• PhD and 5+ years of experience
• Bachelor's degree from an accredited university and 9+ years of experience, or master's degree and 7+ years of experience
• 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/knowledge in cGMP, ICH and regulatory guidelines
• Experience in authoring global regulatory filings and responses to questions
• Knowledge of analytical methods used in in-process clinical drug substance and drug product manufacture
• Excellent writing, organizational, and problem-solving skills
• Demonstrated ability to work collaboratively with cross-functional teams to achieve shared goals
• Proven ability to multitask and manage multiple projects or deliverables simultaneously and prioritize tasks in a fast-paced environment
• Experience managing projects with remote teams and through external alliances preferred
• Familiarity with Microsoft Office productivity software such as Word, PowerPoint, and Excel, and statistical and scientific software such as MiniTab, Origin, or JMP

Benefits

• 401(k) savings plan
• Flexible spending accounts
• Employee assistance program
• Tuition reimbursement program
• Medical, dental and vision coverage
• Life insurance
• Disability insurance
• Generous Paid Time Off
• Four Day Work Week