About Alto Neuroscience, Inc. 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. Backed by Stanford.
About the role
Alto Neuroscience is an equal-opportunity employer that does not discriminate on the basis of sex, age, race, color, religion, marital status, sexual orientation, gender identity, pregnancy, disability, or any other characteristic protected by law. We offer a welcoming and inclusive environment in service to one another, our products, the diverse consumers we represent, and the communities we call home. We do all of this with kindness, empathy and respect for each other.
What they're looking for
- 10+ years of CMC quality experience in biotech/pharma, including direct CMO/CDMO oversight
- Experience supporting late-stage (Phase 3) or commercial-track CMC quality programs
- Strong working knowledge of FDA GMP requirements and change control/deviation/CAPA systems
- Experienced in conducting GMP and Clinical Supply vendor site audits
- 6–9 years of CMC quality experience with meaningful CMO oversight exposure
- B.S in a scientific discipline (e.g. chemistry, biochemistry, biology, life sciences)
More about this role
Primary Role
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.
What you'll do
Quality Oversight
- 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 initiated change controls, deviations, and CAPA processes.
- Lead or support GMP audits of manufacturing and...
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