Source Job

• Execute analytical strategies for commercial products, ensuring compliance and method lifecycle management.
• Lead method transfer, validation, and investigations at CDMOs, supporting regulatory submissions.
• Serve as analytical SME, partnering cross-functionally to ensure quality and supply continuity.

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into therapies for central nervous system disorders. The company fosters a culture of trust, ownership, curiosity, and results with a collaborative team.

• Manage analytical development, QC, and stability activities at contract manufacturing sites.
• Author and review CMC sections for US and ex-US regulatory filings.
• Collaborate with Quality Assurance to close investigations and manage change controls.

BridgeBio is a biotech company that pioneered a 'moneyball for biotech' approach, pooling projects and early-stage research to reduce risk and develop medicines for rare diseases. They foster a culture of curiosity and experimentation with small teams of experts.