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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in biomaterials lifecycle management and regulatory documentation for USDA approval, with strong technical writing skills and experience in cross-functional collaboration within the animal health biologics sector.
Highest-signal resume keywords
Biomaterials Lifecycle ManagementTechnical Writing for Regulatory ReviewUSDA Regulatory ExperienceMethod Validation and TransferCross-Functional Collaboration
ATS Keywords
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Hard Skills
Biological Method Platform ExpertiseImmunoassaysCell-Based MethodsBiomaterials QualificationTechnical Documentation Preparation
Soft Skills
LeadershipCommunication
Tools & Technologies
Regulated Quality Systems
Certifications & Qualifications
Bachelor’s Degree in Biological ScienceValid Driving License
Industry Keywords
Animal Health BiologicsUSDA ApprovalBiomaterials Inventory ManagementMethod RemediationQuality Control Laboratories
About the role
Key responsibilities & impact- Provide technical and program leadership for the lifecycle management of critical biomaterials used in animal health biologics production and testing
- Lead biomaterials knowledge management, including production history, characterization, inventory status, qualification status, and method dependencies
- Manage biomaterials inventory strategy, including reorder levels, usage trends, lead times, expiry risks, and replacement triggers
- Lead replacement biomaterials planning through outsourcing, commercial vendors, and internal sourcing options
- Design, coordinate, and document equivalence qualification studies for replacement biomaterials to support USDA approval
- Lead or support method remediation when biomaterial changes or performance issues impact biological test methods
- Coordinate transfer of biomaterials and remediated methods to QC laboratories
- Prepare technical reports, qualification summaries, scientific justifications, and regulatory support documents for USDA review
- Partner cross-functionally with Manufacturing, QC, QA, Regulatory Affairs, R&D, 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 7 years of experience in USDA-regulated animal health biologics
- Minimum of 5 years of experience qualifying and preparing biomaterials-related technical documentation for regulatory review
- Subject matter expertise in at least one biological method platform, such as immunoassays, cell-based methods, or other relevant biological test systems
- Strong technical writing skills with the ability to prepare clear, science-based, regulator-ready reports and justifications
- Experience working with USDA
- Experience with regulated quality systems
- Experience with method validation and transfer
- Experience collaborating across Manufacturing, QC, QA, Regulatory Affairs, R&D, and external organizations
- Required valid driving license
- No visa sponsorship
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
- Domestic relocation
- 10% travel