Scientist / Sr. Scientist - Biopharm Pilot Registration Lab

Role Summary

Scientist / Sr. Scientist - Biopharm Pilot Registration Lab role focusing on development, scale-up, and technology transfer of CHO-expressed monoclonal antibodies for veterinary use in a GMP environment, based in Lincoln, Nebraska, with global collaboration.

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

Qualifications

• Advanced degree in biological sciences, chemical engineering, or related field is preferred
• For Scientist: BS and 7+ years of experience or MS and 6+ years of experience
• For Sr. Scientist: MS and 15+ years of experience or PhD and 1-2 years of experience
• Significant practical experience and theoretical knowledge of downstream processing (centrifugation, filtration, chromatography) and upstream cell culture.
• Proven track record in GMP-regulated environments, including process scale-up and tech transfer to commercial facilities.

Skills

• Strong scientific and engineering background in the principles for process scale-up and robustness
• Experience with instrumentation, control systems, and advanced troubleshooting for pilot-scale GMP operations, including practical experience with automated control and data capture systems such as SCADA, Delta V, and Unicorn
• Knowledge of equipment specification, qualification, operation, and maintenance in a regulated environment
• Experience with large-scale single-use bioreactor technology and mammalian cell culture is desirable
• Working knowledge of GMP systems (change control, SAP, LIMS) is desirable
• Willingness to work flexible hours, including after-hours monitoring as needed
• Ability to perform physically demanding tasks typical of a pilot-scale lab environment
• Excellent aseptic technique
• Experience with cGMPs, inspection, and compliance in a pilot lab setting
• Demonstrated ability to work independently on multiple concurrent programs
• Familiarity with regulatory frameworks for veterinary biopharmaceuticals is desirable
• Strong organizational and people skills
• Excellent written and verbal communication skills
• Proven ability to work effectively as part of a collaborative team