Scientist - Product Development Quality

Zoetis•Lincoln, NE

About The Position

Provide quality assurance and compliance expertise for Veterinary Medicine Research & Development (VMRD), supporting the design, execution, scale-up, and transfer of new or improved biological and biopharmaceutical products and processes. Help ensure VMRD production facilities, products, and processes meet applicable USDA, EU, FDA, Zoetis, and destination-country requirements. Work with Development Science & Technology colleagues on technical transfers and regulatory coordination, and serve as a quality assurance consultant for development, clinical, and VICH batches or serials. The position supports colleagues and initiatives by providing regulatory documents and manufacturing quality and compliance resources. It reviews and approves product and manufacturing documentation, validation work, changes, and quality investigations; supports preparation and review of regulatory submissions; and helps maintain compliance across Lincoln Operations and supplier processes. The role also contributes technical and regulatory expertise, identifies and recommends solutions to quality issues, and may train, coach, mentor, or supervise colleagues. Work is performed under limited supervision, with responsibility for a portion of team milestones and deliverables.

Requirements

Bachelor's degree with 10 years of relevant experience, or a 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, including the ability to collaborate effectively 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/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 requirements.
Work with VMRD Development Science & Technology colleagues on scale-up, technical transfers, and regulatory issue coordination.
Serve as a quality assurance consultant for development, clinical, and VICH batches or serials.
Provide VMRD colleagues with regulatory documents and manufacturing quality and compliance resources.
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 involving manufacturing, packaging, product testing, sterility assurance, and other GMP functions.
Guide and oversee root-cause identification, corrective and preventive actions (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 processes, systems, and facilities that provide quality products.
Author risk assessments as needed within project teams.
Participate in teams and recommend actions to maintain regulatory compliance within Lincoln Operations.
Advise management of regulatory deficiencies and recommend 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 work group, team, or function goals and take responsibility for a portion of team milestones or deliverables.
Investigate problems and propose solutions, including modifying processes to improve work group or function efficiency.
May provide training, coaching, or mentoring within a work group or team, and may supervise colleagues.