Senior Associate Scientist - Biopharmaceutical Pilot Registration Lab

Zoetis; Lincoln (NE); On-site; USD 95,000 - 135,000; Full time

Job summary

Zoetis in Lincoln, Nebraska, is seeking a Senior Associate Scientist to support development, scale-up and tech transfer of CHO-expressed monoclonal antibodies for veterinary use within a GMP environment.

You will collaborate with multidisciplinary teams to ensure smooth transitions from development to pilot to commercial manufacturing, with hands-on work in upstream/downstream processing and strong documentation practices.

Qualifications

• Bachelor-level degree in biological sciences, chemical engineering, or related field.
• Experience with upstream cell culture and/or downstream processing in GMP settings.
• Proven GMP track record including process scale-up and tech transfer.

Responsibilities

• Set up and troubleshoot large-scale expression and purification equipment.
• Lead cross-functional teams in process transfer and scale-up.
• Author and review process docs, SOPs, and tech transfer filings.
• Support upstream cell culture from shake flask to 2000-L scales.
• Drive workflow improvements and maintain GMP-compliant docs.
• Perform preventative maintenance on lab equipment.
• Maintain steam-in-place procedures and equipment cleaning.
• Ensure regulatory compliance and accurate record-keeping.

Skills

Cell culture

Downstream processing

Tech transfer

GMP compliance

SOP documentation

Data capture systems

Education

Biological sciences degree

Chemical/biochemical engineering degree

Advanced degree preferred

Tools

SCADA

DeltaV

Unicorn

LIMS

SAP

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

About Zoetis

At Zoetis, our purpose is to nurture the world and humankind by advancing care for animals. As a Fortune 500 company and the world leader in animal health, we discover, develop, manufacture and commercialize vaccines, medicines, diagnostics and other technologies for companion animals and livestock. We know our people drive our success. Our award-winning culture, built around our Core Beliefs, focuses on our colleagues' careers, connection and support. We offer competitive healthcare and retirement savings benefits, along with an array of benefits, policies and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources.