Senior Manager, CMC Quality Assurance

About the role

At Alto Neuroscience, you will play a pivotal role in advancing precision psychiatry and improving how mental health disorders are treated. Join us in building the next generation of personalized neuroscience-based therapeutics. We are seeking an experienced Director/Senior Manager, CMC Quality to provide quality oversight for Chemistry, Manufacturing, and Controls (CMC) and Clinical Supplies activities across Alto's drug substances, drug products, and packaged products, ensuring GMP compliance and inspection readiness as programs move toward registrational and eventually commercial manufacturing. Level will flex based on candidate experience.

Responsibilities

• Manages the QA oversight of GMP manufacturing vendors, including involvement and review of method validation documentation, stability protocols and reports, GMP drug substance and drug product specifications, GMP drug substance and drug product master/executed batch records, and GMP drug substance and drug product release.
• Manages the QA oversight of GMP Clinical Supply vendors, including master/executed batch record reviews, and Clinical Supply release.
• Attend vendor meetings with the applicable functional areas and ability to provide quality feedback.
• Provide quality input to CMC Operations for vendor