Animal Regulatory Manager
At SAB Biotherapeutics (SAB), we’re using the sophistication of science and genius of nature to change the landscape of human health. Our team of scientists, researchers and professionals has made it their life's work–with technology and tenacity–to pioneer a new powerful platform to make an impact that’s global + personal.
Through advanced genetic engineering and antibody science, we are dedicated to advancing a new class of immunotherapies, leveraging the native human immune response, with first-in-class and best-in-class potential across broad therapeutic categories including autoimmune, inflammation, infectious disease and immune-oncology. SAB-185, is among the elite therapy candidates for COVID-19, advancing with Operation Warp Speed. As true innovation, our novel platform is also being developed in a rapid response capacity for future pandemic response.
The Animal Regulatory Manager is responsible for managing all animal regulatory activities and maintaining full compliance with all laws, regulations, and contractual responsibilities related to all projects that include the use of animals. This position requires knowledge and experience in compliance with animal care and use laws/regulations, knowledge/background in the biological sciences, as well as strong organizational, management, and interpersonal skills. This position also requires familiarity with a variety of the field’s concepts, best practices, and procedures.
Essential Duties and Responsibilities:
• Administration of SAB’s Institutional Animal Care and Use Committee (IACUC) and ensuring the highest standards of compliance with the Animal Welfare Act and regulations, the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, the Guide for the Care and Use of Laboratory Animals, the Guide for the Care and Use of Agricultural Animals in Research and Teaching, and any other applicable guidelines or requirements.
· General IACUC responsibilities include coordination of semiannual meetings and inspections, maintaining records and documentation in a well-organized and easily retrievable manner (paper and digital), effectively communicating with committee members, facilitating protocol submission, review, and approval, and filing reports as required.
· Working directly with agencies to maintain compliance including but not limited to the United States Department of Agriculture Animal and Plant Health Inspection Service Animal Care program (USDA APHIS AC), the National Institutes of Health Office of Laboratory Animal Welfare (NIH OLAW), NIH Office of Science Policy (NIH OSP), and the Department of Defense Animal Care and Use Review Office (ACURO).
· Coordination of IACUC oversight of animal care and use at subsidiary company SAB Capra.
· Maintenance of accreditation with AAALAC International
· Leadership in conjunction with safety, laboratory, and animal care personnel of the Institutional Biosafety Committee (IBC). Tasks include coordination of semiannual meetings and inspections, fulfillment of all regulatory requirements, and ensuring company-wide compliance with the biosafety program regarding personnel safety, animal care, and the use of biological agents and recombinant nucleic acids including research involving animals and physical containment requirements.
· Interaction with the Food and Drug Administration’s Center for Veterinary Medicine (FDA CVM) with regards to ongoing submission of a New Animal Drug Application (NADA) for review and approval. This will include preparation of data and submission materials pre-approval and periodic drug experience reporting post-approval.
· Procure, maintain, and ensure compliance with permits for transportation of and export/import of animal products and organisms/vectors both interstate and internationally as required by USDA APHIS.
Supervisory Responsibilities: This position does not supervise employees currently.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Education, Experience and Certifications: Requires a bachelor’s degree in biology or other relevant fields with 3-5 years of experience in animal regulatory and biopharmaceutical development preferred. General understanding of animal care and use programs and pharmaceutical industry activities and development processes also preferred.
Language Skills: Must have strong oral and written communication skills. The ability to write in-depth technical reports that require knowledge in the biological sciences and detail structure, procedures, and outcomes is critical. Must be proficient in Microsoft Office software (Word, Excel, PowerPoint, and Outlook). Ability to effectively present information in one-on-one and group settings.
Mathematical Skills: Utilize established mathematical and scientific techniques to compile and analyze data and put together effective and accurate reports.
Physical Demands: While performing the duties of this job, the employee is regularly required to walk, stand, and sit. The employee will be able to use a computer for long periods at any given time. The employee must occasionally lift and/or move up to 10 pounds.
Working Environment: Normal office working conditions.
ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.