Scientist - Product Development Quality

Zoetis•Lincoln, NE

About The Position

Provide quality assurance and compliance expertise for Veterinary Medicine Research & Development (VMRD), including the design, execution, and transfer of new biological and biopharmaceutical products to help achieve department and site objectives. The role ensures that production facilities, product and process transfers, and quality systems comply with applicable USDA, EU, FDA, Zoetis, and destination-country requirements. The Scientist partners with Development Science & Technology colleagues on scale-up, technical transfers, regulatory issues, and QA support for development, clinical, and VICH batches or serials. The role reviews and approves manufacturing, analytical, validation, and regulatory documents; investigates deviations; oversees CAPAs; evaluates changes to GMP processes and systems; and supports supplier quality and continued regulatory compliance at Lincoln Operations. This position applies substantial technical and functional knowledge independently, works under limited supervision, and resolves moderately complex issues amid uncertainty. It contributes to team and function goals, improves processes, may serve as a technical resource, and may provide training, coaching, or mentoring or supervise colleagues.

Requirements

Bachelor's degree with 10 years of relevant experience, master's degree with 8 years of relevant experience, or an equivalent combination of education and experience in biological or pharmaceutical sciences, engineering, or a related discipline.
At least 5 years of progressive experience in Quality Assurance, Manufacturing, Quality Control, or Regulatory Affairs in the veterinary or human pharmaceutical or biological products industry.
Experience with Quality Assurance auditing, current Good Manufacturing Practices (cGMP), and quality systems.
Technical understanding of aseptic practices.
Thorough knowledge of U.S. and EU regulations governing biological products and their practical application.
Strong technical and analytical skills, including the ability to evaluate information, draw sound conclusions, and make informed decisions.
Knowledge of Right First Time (RFT) and Lean principles.
Strong written and verbal communication skills and the ability to collaborate with internal and external stakeholders at all levels.
Demonstrated interpersonal skills and ability to build effective working relationships.
Excellent organizational skills and strong attention to detail and accuracy.
Ability to adapt to changing conditions and priorities while maintaining flexibility and effectiveness.

Nice To Haves

Master's or PhD degree in a biological science or chemical or bioprocess engineering.
Expert-level competency in validation of processes, equipment, cleaning procedures, software, and computerized systems.
Solid knowledge of Zoetis biological and biopharmaceutical products.

Responsibilities

Ensure VMRD production facilities and transfers of newly developed or improved biological and biopharmaceutical products and processes comply with applicable USDA, EU, FDA, Zoetis, and destination-country regulatory requirements.
Partner with VMRD Development Science & Technology colleagues on scale-up, technical transfers, and regulatory issue coordination.
Serve as a QA consultant for development, clinical, and VICH batches or serials; provide regulatory documents and manufacturing quality and compliance resources to VMRD colleagues and initiatives.
Review new product master batch records, manufacturing documents, and analytical documents for accuracy, completeness, and compliance with Outlines of Production and submissions; provide QA approval.
Review and approve validation protocols and reports.
Work with VMRD, VMRA, and GMS to prepare and review Outlines of Production and submissions.
Conduct and review deviation investigations related to manufacturing, packaging, product testing, sterility assurance, and other GMP functions; guide and oversee root-cause analysis, CAPAs, and CAPA effectiveness checks.
Evaluate and approve changes to manufacturing and packaging equipment and processes, testing, IT systems, and other GMP documents and programs.
Ensure outside suppliers of raw materials and components procured by Lincoln Operations maintain suitable processes, systems, and facilities to provide quality products; prepare risk assessments as needed within project teams.
Participate in teams and make recommendations to maintain regulatory compliance within Lincoln Operations.
Advise management of regulatory deficiencies and recommend appropriate regulatory actions when products do not meet Zoetis or government requirements.
Maintain contemporary technical and regulatory knowledge relevant to vaccine and biopharmaceutical development.
Contribute to team milestones and deliverables, investigate problems, and propose solutions or process improvements.
May provide training, coaching, or mentoring and may supervise colleagues.