Technology Transfer Officer

USV

Job Location:

Diu - India

Monthly Salary: Not Disclosed

Posted on: 4 hours ago

Vacancies: 1 Vacancy

Job Summary

Process Scale-up: Assist in the transfer of OSD products from R&D/Formulation Development to commercial manufacturing scales (Granulation Compression Coating).
Trial Monitoring: Supervise Scale-up and Exhibit batches to identify critical process parameters (CPPs) and ensure consistency.
Documentation: Draft and review Technology Transfer Dossiers (TTD) Process Validation Protocols and Master Formula Records (MFR).
Troubleshooting: Identify and resolve process-related issues like weight variation hardness fluctuations or coating defects during the transfer phase.
Optimization: Recommend process improvements to enhance yield reduce cycle time and ensure the robust scalability of new products.
Cross-Functional Coordination: Act as a bridge between R&D Production and Quality Assurance to ensure seamless product integration.
Gap Analysis: Conduct technical assessments of equipment capabilities between the lab and the manufacturing plant to ensure compatibility.
Compliance: Ensure all transfer activities and documentation comply with regulatory guidelines (e.g. SUPAC ICH Q8/Q9/Q10).

Required Experience:

Unclear Seniority

Process Scale-up: Assist in the transfer of OSD products from R&D/Formulation Development to commercial manufacturing scales (Granulation Compression Coating).Trial Monitoring: Supervise Scale-up and Exhibit batches to identify critical process parameters (CPPs) and ensure consistency.Documentation:...