Position Summary:
 We are seeking a Manufacturing Associate, Downstream to join our multi-product manufacturing facility. This role plays a key part in downstream processing operations while adhering to cGMP requirements and established Standard Operating Procedures. The Manufacturing Associate will support production activities, documentation, equipment preparation, and materials coordination to ensure timely release of high-quality products. Our culture is built on Integrity, Adaptability, Innovation, Teamwork, and Passion, all driven by a shared mission to positively impact patients’ lives.

Key Responsibilities:

• Prepare and set up equipment and materials for scheduled production runs
• Plan and coordinate resources required for manufacturing processes
• Operate and maintain bioprocess chromatography skids
• Pack, unpack, clean, and maintain production-scale chromatography columns
• Perform antibody and enzyme purification using techniques such as Affinity, Size Exclusion, Ion Exchange, Hydrophobic Interaction chromatography, and Tangential Flow Filtration (TFF)
• Calibrate and test pH and conductivity meters
• Execute filtration processes, including sterile, ultrafiltration, and viral filtration
• Demonstrate strong aseptic techniques during all applicable operations
• Support aseptic filling activities, including media fills and qualification runs
• Maintain cleanroom cleanliness and equipment readiness
• Monitor and manage raw material inventory
• Ensure accurate and compliant GMP documentation
• Create, revise, and execute Batch Production Records, SOPs, protocols, and reports
• Lead or support independent projects as assigned
• Prepare media and buffer solutions for manufacturing processes

Preferred Qualifications:

• Associate or Bachelor’s degree, preferably with a focus in biology or chemistry

Work Schedule:
 This is a full-time position working Monday through Friday, 8-hour shifts between 8:00 AM and 5:00 PM. Flexibility to work overtime, weekends, or holidays may be required based on business needs.

KPG123