Senior Associate Scientist - Biopharmaceutical Pilot Registration Lab

zoetis; Oklahoma; On-site; USD 90,000 - 140,000; Full time

Job summary

Zoetis is seeking a Senior Associate Scientist for the Biopharmaceutical Pilot Registration Lab in Lincoln, NE. You will lead scale-up, tech transfer, and GMP-compliant deployment of CHO-expressed monoclonal antibodies for veterinary use.

Expect hands-on work in upstream/downstream processing and cross-functional collaboration across global partners. The role emphasizes process documentation, regulatory filings, and robust transfer to pilot and commercial facilities.

Qualifications

• Bachelor's degree in biological sciences or related field; advanced degree advantageous.
• Significant practical experience in upstream cell culture and/or downstream processing (centrifugation, filtration, chromatography).
• GMP-regulated experience including process scale-up and tech transfer to commercial facilities.

Responsibilities

• Set up, operate, troubleshoot large-scale equipment for expression and/or purification of therapeutic proteins.
• Lead cross-functional teams to drive process optimization and scale-up; manage tech transfer to manufacturing.
• Author and review process docs, SOPs, protocols, and regulatory filings with scientific rigor.

Skills

GMP experience

Tech transfer

Process scale-up

Documentation

Cross-functional teamwork

Aseptic technique

Education

Bachelor's degree in biological sciences

Advanced degree advantageous

Tools

SCADA

DeltaV

Unicorn

LIMS

Job description

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.

Position Responsibilities

• 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

Education and Experience

• 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.

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 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

Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants