Scientist / Sr. Scientist - Biopharmaceutical Pilot Registration Lab

Role Description

As a Scientist in the Biopharmaceutical Pilot Registration Lab, you will play a vital role in the development, scale-up, and technology transfer of CHO-expressed monoclonal antibodies for veterinary use. You will operate in a GMP-regulated environment, collaborating with multidisciplinary teams to ensure a successful transition from development to pilot to commercial manufacturing. This role requires hands-on technical expertise in downstream processing, as well as strong organizational and communication skills. The position is based in Lincoln (Nebraska, USA) with frequent interactions with colleagues and external partners located around the globe.

Position Responsibilities

• Advanced experience in setting up, programming, operating and troubleshooting large-scale equipment for purification of recombinant therapeutic proteins
• Execute GMP batches for downstream purification (centrifugation, chromatography, precipitation, ultrafiltration, sterile filtration)
• Support upstream operations (aseptic inoculation, cell culture growth at 50L-2000L scale)
• Perform preventative maintenance on portable and stationary equipment
• Maintain, clean, and perform steam-in-place procedures for equipment
• Demonstrate advanced expertise in authoring and reviewing process documentation, SOPs, protocols, technology transfer documents and regulatory filings ensuring the highest standards of scientific rigor and quality
• Ensure accurate and compliant record-keeping in accordance with current GMP standards
• Represent the lab as a key technical leader in cross-functional project teams, collaborating with process development and manufacturing teams, driving process optimization and scale-up, ensuring seamless, high-quality technology transfer
• Drive continuous improvement by optimizing existing workflows and procedures

Education and Experience

Technical Skills Requirements

Full time

Regular

Colleague

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