GMP Downstream Bioprocess Specialist II

Piper Companies; Gaithersburg (MD); On-site; USD 52,000 - 80,000; Full time

Benefits offered by this job

Medical, Dental, Vision (through Cigna

401k

PTO & Holidays

Job summary

Piper Health and Sciences in Gaithersburg, MD is seeking a Manufacturing Associate II to support the downstream manufacturing team. The role involves operating and maintaining downstream processing equipment, performing filtration and chromatography, and ensuring GMP compliance in a cleanroom environment.

Ideal candidates have 3+ years in GMP settings (1+ year in downstream), experience with chromatography, TFF, aseptic processing, and a science degree.

Qualifications

• 3+ years in GMP environment (biotech/pharma) with 1+ year in downstream manufacturing.
• Experience with chromatography, filtration techniques, aseptic processing, and TFF.
• Experience with aseptic technique and working in a BSC (biological safety cabinet).
• Understanding of cGMP (current Good Manufacturing Practices)
• Bachelor's degree in a science-related field.

Responsibilities

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

Skills

GMP experience

Downstream manufacturing

Chromatography

Filtration

Aseptic processing

TFF

Biotech/Biopharma

Education

Bachelor's degree in science

Job description

Piper Health and Sciences in Gaithersburg, MD is seeking a Manufacturing Associate II to support the downstream manufacturing team. The role involves operating and maintaining downstream processing equipment, performing filtration and chromatography, and ensuring GMP compliance in a cleanroom environment.

Ideal candidates have 3+ years in GMP settings (1+ year in downstream), experience with chromatography, TFF, aseptic processing, and a science degree.