- Hands-on experience in conducting, planning, and monitoring In-vitro Skin Permeation Testing (IVPT) studies, including development, validation, pilot studies, and pivotal studies.
- Thorough knowledge and complete understanding of FDA requirements for IVPT studies.
- Expertise in data interpretation and day-to-day troubleshooting related to IVPT studies.
- Experience in the review of raw data and the preparation of protocols and reports for development, validation, pilot, and pivotal IVPT studies.
- Adherence to compliance and regulatory requirements for in-vitro studies.
- Implementation and revision of Standard Operating Procedures (SOPs) related to IVPT studies.
- Valuable subject knowledge related to Bio-analytical methods, Bio-sample analysis, and the interpretation of bioanalytical data.
- Ensuring routine calibration and preventive maintenance of IVPT lab instruments are completed within timelines.
- Experience in writing justifications and designing experiments to address Agency deficiencies related to IVPT.
- Review and preparation of Module 5 documentation for IVPT.
- Interaction with cross-functional teams to meet project timelines.