Technology Transfer - Sterile - Executive
Job Description
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.