Senior Associate Scientist - Biopharmaceutical Pilot Registration Lab

Zoetis • Lincoln, NE

35d • Onsite

About The Position

As a Senior Associate Scientist in the Biopharmaceutical Pilot Registration Lab, you will support the development, scale-up, and technology transfer of CHO-expressed monoclonal antibodies for veterinary use. The role operates in a GMP-regulated environment and collaborates with multidisciplinary teams to transition processes from development through pilot and commercial manufacturing. It requires hands-on expertise in upstream and/or downstream processing, along with strong organizational and communication skills. The position is based in Lincoln, Nebraska, with frequent interactions with colleagues and external partners around the globe.

Requirements

• Bachelor's degree at minimum in biological sciences, chemical engineering, or a related field.
• Significant practical experience and theoretical knowledge of upstream cell culture and/or downstream processing, including centrifugation, filtration, and chromatography.
• Proven experience in GMP-regulated environments, including process scale-up and technology transfer to commercial facilities.
• Strong scientific and engineering background in process scale-up and robustness.
• Experience with instrumentation, control systems, and advanced troubleshooting for pilot-scale GMP operations, including 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.
• 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.
• Ability to work independently on multiple concurrent programs.
• Strong organizational and people skills.
• Excellent written and verbal communication skills.
• Ability to work effectively as part of a collaborative team.

Nice To Haves

• An advanced degree.
• Working knowledge of GMP systems such as change control, SAP, and LIMS.
• Familiarity with regulatory frameworks for veterinary biopharmaceuticals.

Responsibilities

• Set up, program, operate, and troubleshoot large-scale equipment for mammalian cell culture expression and/or recombinant therapeutic protein purification.
• Represent the lab as a technical leader on cross-functional project teams; collaborate with process development and manufacturing teams to optimize and scale up processes and support high-quality technology transfer.
• Author and review process documentation, SOPs, protocols, technology transfer documents, and regulatory filings.
• Execute and support upstream cell culture, from shake flask to 2000-L production scale, and/or downstream purification, including centrifugation, chromatography, and filtration, to produce GMP batches of drug substance.
• Optimize existing workflows and procedures through continuous improvement.
• Maintain accurate and compliant documentation in accordance with current GMP standards.
• Perform preventative maintenance on portable and stationary equipment.
• Maintain and clean equipment and perform steam-in-place procedures.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior