Senior Associate Scientist - Biopharmaceutical Pilot Registration Lab

Zoetis Spain SL; Oklahoma; On-site; USD 110,000 - 140,000; Full time

Job summary

Zoetis seeks a Senior Associate Scientist for the Biopharmaceutical Pilot Registration Lab in Lincoln, NE, to develop, scale-up, and transfer CHO-expressed monoclonal antibodies for veterinary use. You will work in a GMP setting with diverse teams, focusing on translating development to pilot and commercial manufacturing.

You will lead process scale-up, documentation, and regulatory filings, and ensure high-quality technology transfer and compliance across stages of development.

Qualifications

• Bachelor’s degree in biological sciences, chemical engineering, or related field.
• Experience in upstream cell culture and/or downstream processing in GMP environments.
• Proven record in process scale-up and tech transfer to pilot/commercial facilities.

Responsibilities

• Set up and troubleshoot large-scale expression and purification equipment.
• Lead cross-functional teams for process optimization and tech transfer.
• Author and review process documents, SOPs and regulatory filings.
• Perform upstream cell culture and/or downstream purification to GMP batches.
• Drive continuous improvement and ensure GMP compliance.
• Maintain equipment and support QC and regulatory readiness.

Skills

Process scale-up

GMP experience

Cross-functional collaboration

Technical leadership

Documentation & regulatory filings

Education

Bachelor's in biological sciences or chemical engineering

Advanced degree advantageous

Tools

SCADA

DeltaV

Unicorn

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 without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at [e-mail] to request an accommodation.

Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act.

All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact.

At Zoetis, our purpose is to nurture our 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.