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About the role
Key responsibilities & impact- Maintain biomaterials documentation, including production history, characterization, inventory status, qualification status, and method dependencies
- Monitor biomaterials inventory, usage trends, expiry risks, and reorder triggers
- Support biomaterials replacement planning, sourcing evaluations, and equivalence qualification activities
- Assist with method remediation when biomaterials impact biological method performance
- Support transfer of biomaterials and remediated methods to QC laboratories
- Draft or contribute to technical reports, qualification summaries, scientific justifications, and regulatory support documents for USDA or CVB review
- Collaborate with Manufacturing, QC, QA, Regulatory Affairs, R&D, Supply Chain, and external suppliers
Requirements
What you’ll need- Bachelor’s degree in a biological science, such as Biology, Microbiology, Genetics, Virology, or a closely related discipline
- Minimum of 5 years of experience in USDA-regulated animal health biologics or veterinary biologics
- Developing subject matter expertise in at least one biological method platform, such as immunoassays, cell-based methods, or other relevant biological test systems
- Strong scientific documentation and technical writing skills
- Experience qualifying biomaterials or preparing biomaterials-related technical documentation for regulatory review preferred
- Experience working with CVB or supporting USDA-regulated veterinary biologics submissions preferred
- Experience with regulated quality systems, method validation, method transfer, or method remediation preferred
- Experience collaborating across multiple departments or external organizations preferred
- No visa sponsorship
- US and Puerto Rico residents only
Benefits
Comp & perks- Annual bonus and long-term incentive, if applicable
- Medical, dental, vision healthcare and other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days
- Hybrid work arrangement
- 10% travel requirement
- Domestic relocation