Zoetis
Scientist / Sr. Scientist Biopharmaceutical Pilot Registration Lab
Zoetis, Lincoln, Nebraska, United States, 68501
Scientist In The Biopharmaceutical Pilot Registration Lab
As a 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 downstream processing, as well as strong organizational and communication skills. The position is based in Lincoln (Nebraska, USA) with frequent interactions with colleagues and external partners located around the globe. Position 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 50L2000L 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 Education and Experience: 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. Technical Skills Requirements: 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
As a 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 downstream processing, as well as strong organizational and communication skills. The position is based in Lincoln (Nebraska, USA) with frequent interactions with colleagues and external partners located around the globe. Position 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 50L2000L 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 Education and Experience: 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. Technical Skills Requirements: 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