- Aibonito, Aibonito, Puerto Rico
- 5+ years
Responsible for planning, executing, and documenting analytical method transfers, validations, verifications, and method improvement initiatives in compliance with regulatory requirements.
Responsibilities
- Coordinate and execute analytical method transfer activities between sending and receiving laboratories
- Prepare method transfer protocols and reports in accordance with internal SOPs and regulatory expectations
- Provide technical training and support during method transfer execution
- Investigate and troubleshoot discrepancies during or after method transfer
- Develop method validation strategies aligned with ICH, FDA, EMA, USP, and other relevant regulatory guidelines
Requirements
- Bachelor’s or Master’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related discipline
- Nice to have: Bilingual Spanish/English