Job Description

Executes bioprocess operations successfully in Purification; Strong/proven experience in both manual and automated chromatography operations UF/DF operations, and bulk filtration. Performs CIP/SIP operations: Cleaning, assembly, sterilization, disassembly, and operation of primary process equipment. Ensures that standard operating procedures (SOPs) and batch records are accurate, and followed in accordance with cGMP regulatory expectations. Recommends and executes projects and changes to bioprocess operations to reduce risk and increase efficiency. Trains Technicians on theories and concepts to support bioprocess operations. Performs review of GMP documentation and participates in training and development opportunities to gain understanding of compliance requirements and departmental policies. Completes required processing documentation including deviation reports, change control, product change over, etc. Ensures acceptable quality and quantity of work executed. Ensures compliance with company quality systems, safety procedures, and other company policies.