Associate Director, Analytical Development & Quality Control
Uniquity Bio Inc. · Posted Nov 7, 2026
- Malvern, Pennsylvania, United States +1 more
- Manager
- 10+ years
Lead analytical development and quality control activities to support biopharmaceutical product development, characterization, manufacturing, and regulatory approval.
Locations (2)
- Malvern, Pennsylvania, United States
- San Diego, California, United States
Responsibilities
- Develop and implement robust analytical methods
- Lead method qualification, validation, and transfer
- Oversee GMP and non-GMP stability studies
- Manage reference standard lifecycle
- Review and approve QC raw data and documentation
Requirements
- Bachelor's degree or higher in analytical chemistry, biochemistry, or related scientific discipline
- Nice to have: late-stage monoclonal antibody drug product development
- Nice to have: PPQ
- Nice to have: BLA submissions
- Nice to have: drug-device combination products