- Boston, Massachusetts, United States
- Full-time · Manager
- $72K–$169K per year
- 4+ years
Lead and manage cGMP Quality Control functions for DNA, mRNA, gRNA, and LNP, ensuring quality of genetic medicines.
Compensation
$72,000 - $169,400
Responsibilities
- Run test method transfer/qualification/validation for GMP methods at contract laboratories to support Drug Substance and Drug Product in-process, release, and stability testing.
- Review and approve method qualification protocols, reports, and test methods.
- Review and approval of all data related to method transfer, qualification, and validation.
- Handle qualification, implementation, and inventory monitoring of reference standards, controls, and critical reagents.
- Manage establishment of method performance trending spreadsheets and lead continuous monitoring activities.
Requirements
- BS Degree in a scientific or related field
- MS Degree in a scientific or related field
- Nice to have: JMP
- Nice to have: SLIM
- Nice to have: Veeva