Protein A Chromatography Scientist for Multi-Cycle Resin Regeneration Study (FPLC, GMP Analytics)

Protein A Chromatography Scientist for Multi-Cycle Resin Regeneration Study (FPLC, GMP Analytics)

Protein A Chromatography Scientist for Multi-Cycle Resin Regeneration Study (FPLC, GMP Analytics)

Upwork

Upwork

Remoto

16 hours ago

No application

About

Job Description: I am seeking an experienced bioprocess freelancer or lab partner to conduct a Protein A chromatography resin regeneration study. The project involves running multi-cycle bind–elute–regeneration experiments (60–100 cycles) and generating GMP-like data packages suitable for technology validation. Scope of Work: Operate a modern FPLC chromatography system (e.g., ÄKTA, Bio-Rad NGC, Tosoh Octave, Knauer AZURA) with inline monitoring of pH, conductivity, UV280, and pressure at ≥1 Hz data logging. Pack and run 5–10 mL Protein A columns (e.g., MabSelect PrismA, Amsphere A3, or equivalent). Prepare alkaline regeneration solutions (NaOH/KOH with sulfite and/or polyol stabilizers), chelator pre-rinse, and quench solutions. Execute 60–100 regeneration cycles per arm (control, sulfite, polyol). Perform analytics at cycles 1, 30, 60, and 100, including: • DBC10 breakthrough curve determination • Pressure drop (ΔP) vs. baseline • Residue assays: sulfite (less than 1 ppm) and polyol (less than 1000 ppm) • Cleanliness: LAL endotoxin (less than 0.1 EU/mL), HCP ELISA (less than 10 ng/mg), bioburden plating (no growth) Provide full documentation: calibration logs, lot numbers, cycle data, CSV exports, QA-style final report. Required Experience: Demonstrated hands-on experience with Protein A chromatography workflows and resin regeneration/lifetime studies. Familiarity with downstream processing of monoclonal antibodies or Fc-fusion proteins. Ability to run or coordinate GMP-relevant analytics (LAL endotoxin, HCP ELISA, bioburden). Strong documentation discipline suitable for buyer-facing validation packages. Deliverables: Complete run logs and raw data (CSV format). Analytical results (residues, endotoxin, HCP, bioburden). Final report summarizing methods, results, deviations, and recommendations.