Scientist - Product Development Quality

Position Responsibilities

• Ensure VMRD production facilities and the transfer of newly developed and/or improved biological/biopharmaceutical products and processes comply with applicable USDA, EU, FDA, and Zoetis quality standards, as well as the regulatory requirements of destination countries.
• Work in conjunction with VMRD Development Science & Technology (DST) colleagues on scale-up, technical transfers and coordination of regulatory issues.
• Serve as QA consultant for development, clinical, and VICH batches/serials.
• Support VMRD colleagues and initiatives by providing regulatory documents and manufacturing quality/compliance resources.
• Review new product master batch records, manufacturing documents, and analytical documents for accuracy, completeness, and compliance with Outlines of Production/submissions, and provide QA approval.
• Review and approve validation protocols and reports.
• Work closely with VMRD, VMRA and GMS in the preparation and review of Outlines of Production/submissions.
• Conduct and review deviation investigations related to the manufacturing, packaging, testing of product, sterility assurance, and all other GMP functions.
• Provide guidance and oversight in identifying root cause, corrective actions/preventative actions (CAPAs), and effectiveness checks of CAPAs.
• Evaluate and approve changes to manufacturing and packaging equipment and processes, testing, IT systems, and other GMP documents and programs.
• Ensure the processes, systems, and facilities of outside suppliers of raw materials and components procured by Lincoln Operations are maintained to provide quality products.
• Author risk assessments as necessary within project teams.
• Ensure continued regulatory compliance within Lincoln Operations by actively participating on teams and making appropriate recommendations when needed to assure compliance.
• Advise Management of regulatory deficiencies and recommend appropriate regulatory actions when products do not meet Zoetis or government requirements.
• Maintain a high level of contemporary knowledge in the technical and regulatory disciplines appropriate to vaccine/biopharmaceutical development.

Education and Experience

Bachelor's degree with a minimum of 5 years of relevant experience, or a master's degree with a minimum of 3 years of relevant experience, or equivalent combination of education and experience in biological or pharmaceutical sciences, engineering, or a related discipline. Minimum of 2+ years of progressive experience in Quality Assurance, Manufacturing, Quality Control, or Regulatory Affairs within the veterinary or human pharmaceutical or biological products industry.

Technical Skills and Competencies

• 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, with 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, with the ability to effectively communicate and collaborate with internal and external stakeholders at all levels.
• Demonstrated interpersonal skills and the 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.

Preferred Qualifications

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