Scientist / Sr. Scientist – Biopharmaceutical Pilot Registration Lab at Zoetis

Lincoln, Nebraska, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceuticals, VeterinaryIndustries

Requirements

Advanced degree in biological sciences, chemical engineering, or related field 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
Strong scientific and engineering background in principles for process scale-up and robustness
Experience with instrumentation, control systems, and advanced troubleshooting for pilot-scale GMP operations, including 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 desirable
Working knowledge of GMP systems (change control, SAP, LIMS) desirable
Willingness to work flexible hours, including after-hours monitoring
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 desirable
Strong organizational and people skills
Excellent written and verbal communication skills
Proven ability to work effectively as part of a collaborative team

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
Drive process optimization and scale-up, ensuring seamless, high-quality technology transfer
Drive continuous improvement by optimizing existing workflows and procedures