Technology Transfer Sterile Executive
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Job Summary
Technical Transfer (TT): Sterile Executive
Technology Transfer Execution: Execute the successful scale-up and transfer of sterile formulations (injectables ophthalmic lyophilized products) from R&D to commercial production lines.
Process Validation: Author review and execute Technology Transfer protocols Process Validation (PV) protocols and Media Fill protocols in compliance with global regulatory standards (USFDA EMA MHRA).
Trial & Exhibit Batches: Supervise the manufacturing of scale-up trials engineering batches and regulatory exhibit batches in Grade A/B cleanroom environments.
Equipment & Scale Selection: Evaluate and establish equivalency between R&D scale equipment and commercial sterile machinery including compounding vessels high-speed filling lines and lyophilizers.
Critical Process Parameters (CPPs): Identify monitor and optimize CPPs such as mixing speeds filtration pressures filling speeds nitrogen purging levels and freeze-drying cycles to ensure product critical quality attributes (CQAs) are met.
Risk Assessment: Lead Quality Risk Management (QRM / FMEA) studies for newly introduced sterile products to identify and mitigate contamination filtration and sterility risks.
Deviation & Investigation: Investigate technical failures scale-up deviations or filter integrity anomalies during tech transfer runs applying root-cause analysis (RCA) tools to implement effective CAPAs.
Cross-Functional Coordination: Collaborate directly with R&D Production Quality Assurance and Regulatory Affairs to compile technical transfer dossiers and support timely submission filings.
