Methods Specialist
MSD•De Soto, KS
•$79,200 - $124,700•Hybrid
About The Position
The Methods Specialist supports biomaterials management and method remediation activities for USDA-regulated animal health biologics. This role helps maintain biomaterials documentation, monitor inventory, support replacement and equivalence qualification activities, assist with QC transfer, and prepare technical documentation for regulatory review.
Requirements
- 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, 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.
Nice To Haves
- Experience qualifying biomaterials or preparing biomaterials-related technical documentation for regulatory review.
- Experience working with CVB or supporting USDA-regulated veterinary biologics submissions.
- Experience with regulated quality systems, method validation, method transfer, or method remediation.
- Experience collaborating across multiple departments or external organizations.
Responsibilities
- 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.
Benefits
- medical
- dental
- vision healthcare
- other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
