Job Description

Develop and optimize purification processes for biological products, including proteins, antibodies, and other biomolecules.
Prepare and maintain process documentation, including batch records, protocols, and validation reports.
Design experiments and analyze data to enhance yield, purity, and operational efficiency.
Work with advanced techniques such as chromatography, ultrafiltration, diafiltration, centrifugation, and precipitation.
Oversee purification operations, ensuring compliance with Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP).
Monitor critical process parameters, such as pH, temperature, and pressure, during scale-up and manufacturing activities.
Operate and maintain purification equipment, including chromatography columns, tangential flow filtration systems, and centrifuges.
Assist in the validation, qualification, and calibration of equipment to meet regulatory requirements.
Troubleshoot purification processes and address technical challenges to minimize deviations and downtime.
Provide technical support to resolve process issues effectively.
Collaborate with engineering teams to design and scale purification systems.
Contribute to the development of scalable solutions for large-scale manufacturing.
Collaborate with Quality Control (QC) teams to analyze intermediate and final products.
Ensure that purification processes meet quality specifications and regulatory standards.
Implement corrective actions and continuous improvement strategies to maintain quality.
Prepare and maintain process documentation, including batch records, protocols, and validation reports.
Ensure compliance with regulatory requirements (e.g., FDA, EMA) and participate in inspections and audits.