Downstream Production and Manufacturing
Core
Leading and executing unit operations in downstream processing for enzyme extraction and purification, operating specialized recovery and drying equipment, and maintaining GMP compliance.
Role type
Senior IC manufacturing engineer (biopharma downstream)
Builds
Purified enzyme products for industrial or therapeutic applications
Domain
Biopharmaceuticals / Enzyme manufacturing
Required skills
Unit operations management, Enzyme extraction protocols, Batch documentation (BMR), CIP/SIP routines, Process parameter monitoring, Equipment operation (Reactors, Filter Presses, Centrifuges), Drying operations (Spray, Rotary Vacuum, Flash)
Preferred skills
GMP compliance, Plant safety standards, Yield optimization
Technologies
Microfiltration, Ultrafiltration, Centrifuges, Spray Dryers, Rotary Vacuum Paddle Dryers, Flash Dryers, Reactors, Filter Presses
Responsibilities
Operate and supervise downstream processing equipment including production Reactors, Filter Presses, MF/UF systems, and industrial Centrifuges; Oversee final product drying operations using Spray Dryers, Rotary Vacuum Paddle Dryers, and Flash Dryers; Execute cell lysis, solid-liquid separation, concentration, precipitation, and enzyme isolation protocols; Monitor key process parameters (pH, temperature, pressure, flux rate, flow rates) to minimize product loss; Complete Batch Manufacturing Records (BMR), Batch Execution Logs, equipment logbooks, and SOPs; Perform standard Cleaning-In-Place (CIP) and Sterilization-In-Place (SIP) routines; Adhere to plant safety protocols and maintain cleanroom/production floor hygiene under cGMP norms.
