Senior R&D Scientist

This is a fully remote position, open to applicants in Nebraska.

📋 Description

• Lead and autonomously manage various veterinary vaccine research and development initiatives from inception to the completion of regulatory filing data packages.

• Act as the scientific lead for one or more programs targeting specific species (e.g., bovine, swine, equine, or aquaculture) or vaccine platform workstreams.

• Design and supervise detailed vaccination-challenge study plans for target animals; analyze intricate efficacy, safety, and immunogenicity data to support licensure recommendations and labeling claims.

• Author and contribute to regulatory submissions for USDA CVB, including Outlines of Production (OoP), Outline of Studies, product license applications, field safety study designs, and submissions for serial release test methods.

• Represent the R&D function in cross-functional project teams, Regulatory Affairs meetings, and interactions with USDA CVB, CROs, and academic partners.

• Lead the development, validation, and technology transfer of immunological assays to support product release testing and GMP-compliant quality systems.

• Keep abreast of the competitive veterinary biologics landscape and emerging disease threats; incorporate findings into portfolio strategies and prioritization recommendations.

• Provide scientific mentoring, performance coaching, and technical training to Scientists I - IV; assist in talent development planning.

• Manage a team of 2-5 scientists.

• Oversee and manage relationships with CROs for outsourced animal studies and analytical tasks; ensure compliance with study protocols and maintain data quality.

• Present updates on program progress, regulatory strategies, and scientific recommendations to senior R&D leadership and cross-functional stakeholders.

⛳️ Requirements

• Ph.D. in Microbiology, Immunology, Animal Science, Virology, or a closely related field with 5+ years of postdoctoral or industry experience; OR a Master's degree with 8+ years of relevant experience in the animal health industry.

• Proven experience in leading veterinary vaccine research programs and generating regulatory-grade preclinical data packages for USDA CVB or an equivalent regulatory authority.

• Extensive knowledge in target animal immunology, veterinary pathogen biology, or correlates of protection in production or companion animal species.

• Familiarity with various veterinary vaccine platforms and multiple target species.

• Experience in authoring USDA regulatory submissions (OoP, license applications) or equivalent regulatory filings (EMA, CVMB, CFIA, or other markets).

• Strong publication record, contributions to patents, or equivalent evidence of scientific productivity in veterinary science.

• Demonstrated scientific leadership and mentoring experience.

• Excellent scientific writing and oral communication skills; ability to influence without direct authority across R&D, Regulatory, Manufacturing, and Commercial functions.

🏝️ Benefits

• PPE and select agent or FAD zoonosis protocols required as applicable.