Senior Associate Scientist - Biopharmaceutical Pilot Registration Lab
Listed on 2026-09-04
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Pharmaceutical
Pharmaceutical Manufacturing, Pharmaceutical Science/ Research
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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