Senior Scientist II, Drug Substance Manufacturing & Development
Company Name: Entrada Therapeutics
Job Overview
Support and lead late-stage drug substance development and manufacturing for Entrada's pipeline programs. Provide oversight for GMP/non-GMP manufacturing, technical support for process development at CDMOs, and resolve manufacturing/testing issues.
Responsibilities
- Review cGMP documentation
- Conduct process risk assessments
- Author and review protocols and regulatory filings
Requirements
- Ph.D. or MS in a relevant field
- Extensive experience in drug substance manufacturing
- Experience in process development, tech transfer, scale-up, and CDMO oversight