Methods Specialist

Job Description

For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way.

Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do.

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.

• 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.

• 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.

• 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.

Adaptability, Adaptability, Analytical Method Transfer, Biocompatibility, Biologics, Biology, Biomaterials, Bioproduction, Bioproducts, Bulk Load, Cell Separation, cGMP Compliance, Column Chromatography, Computer Literacy, Contract Manufacturing, Data Analysis, Environmental Health and Safety (EHS) Management, Equipment Set Up, External Manufacturing, Immunoassays, Lean Manufacturing Tools, Method Development, Method Validation, Microbiology, Process Monitoring {+ 10 more}

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  if you need an accommodation during the application or hiring process.

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.