Piper Health and Sciences is seeking a skilled and motivated Manufacturing Associate II (Downstream) to join a biopharmaceutical company in the Gaithersburg, MD area. The Manufacturing Associate II is a crucial role in supporting the downstream manufacturing team. This position involves operating and maintaining downstream processing equipment, performing filtration and chromatography techniques and supporting production activities in a cleanroom environment.

QUALIFICATIONS OF THE MANUFACTURING ASSOCIATE II:

• 3+ years of professional experience working in a GMP environment (Biotechnology or Pharmaceutical organization) with 1+ years of experience working in downstream manufacturing
• Experience performing chromatography, filtration techniques, aseptic processing, TFF (tangential flow filtration)
• Experience demonstrating aseptic technique and ability to work in a BSC (biological safety cabinet)
• Understanding of cGMP (current Good Manufacturing Practices)
• Bachelor’s degree in science related field

• Execute manufacturing of drug product following GMP guidelines
• Perform buffer and media preparation for downstream processing.
• Operate and maintain chromatography systems for protein purification.
• Conduct tangential flow filtration (TFF) and viral filtration to ensure product purity.
• Perform aseptic processing in a clean room environment, adhering to strict contamination control measures.
• Maintain accurate documentation of manufacturing activities in compliance with GMP regulations.
• Troubleshoot and resolve issues related to downstream processing equipment.