Downstream GMP Bioprocess Specialist II

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

Benefits offered by this job

Medical + Dental + Vision

401k

PTO & Holidays

Sick leave by law

Job summary

Piper Health and Sciences in Gaithersburg, MD is seeking a Manufacturing Associate II to join its biopharmaceutical operations. The role supports downstream manufacturing, operates and maintains processing equipment, and ensures compliance with GMP in a cleanroom environment.

The ideal candidate has 3+ years in GMP settings with upstream/downstream experience, knows chromatography, filtration, TFF, and aseptic processing, and holds a science degree.

Qualifications

• 3+ years of experience in a GMP environment with 1+ year in downstream manufacturing.
• Experience performing chromatography, filtration, aseptic processing, and TFF.
• Experience with aseptic technique and working in a BSC.
• Understanding of cGMP.
• Bachelor's degree in a science-related field.

Responsibilities

• 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 contamination control.
• Maintain accurate documentation of manufacturing activities in GMP compliance.
• Troubleshoot and resolve issues with downstream processing equipment.

Skills

GMP environment experience

Downstream manufacturing experience

Chromatography

Filtration

Aseptic processing

TFF

BSC (Biological Safety Cabinet) use

cGMP knowledge

Documentation / record keeping

Education

Bachelor's degree in science related field

Tools

Chromatography systems

Tangential Flow Filtration (TFF) equipment

Biological Safety Cabinet (BSC)

Job description

Piper Health and Sciences in Gaithersburg, MD is seeking a Manufacturing Associate II to join its biopharmaceutical operations. The role supports downstream manufacturing, operates and maintains processing equipment, and ensures compliance with GMP in a cleanroom environment.

The ideal candidate has 3+ years in GMP settings with upstream/downstream experience, knows chromatography, filtration, TFF, and aseptic processing, and holds a science degree.