Senior Associate Scientist - Biopharmaceutical Pilot Registration Lab

Role Description As a Senior Associate 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 upstream and/or downstream processing, as well as strong organizational and communication skills.

The position is based in Lincoln, Nebraska with frequent interactions with colleagues and external partners located around the globe.

• Advanced experience in setting up, programming, operating and troubleshooting large‑scale equipment for expression (mammalian cell culture) and/or purification of recombinant therapeutic proteins
• 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
• 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
• Hands‑on execution and support of upstream cell culture (shake flask to 2000‑L production scale) and/or downstream purification (centrifugation, chromatography, filtration) to produce GMP batches of drug substance.
• Drive continuous improvement by optimizing existing workflows and procedures
• Ensure accurate and compliant documentation in accordance with current GMP standards
• Perform preventative maintenance on portable and stationary equipment
• Maintain, clean, and perform steam‑in‑place procedures for equipment

• Bachelor's degree (minimum) in biological sciences, chemical engineering, or related field. Advanced degree would be advantageous.
• Significant practical experience and theoretical knowledge of upstream cell culture and/or downstream processing (centrifugation, filtration, chromatography)
• Proven track record in GMP‑regulated environments, including process scale‑up and tech transfer to commercial facilities.

• 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 bioreactor and/or purification equipment
• 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
• 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

Full time Regular Colleague

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