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regulatory affairs flow cytometry assay development bioanalysis cdx📋 Description
- Provide full operational oversight of Frederick, MD labs (Bioanalysis, Flow Cytometry, CDx)
- Establish and monitor KPIs such as quality, turnaround time, capacity, revenue, and budget
- Drive operational excellence through resource allocation, capacity planning, and process optimization
- Lead CDx programs from concept through development, validation, to lifecycle management
- Ensure regulatory compliance with FDA, IVDR, ISO 13485/15189, CLIA, CLSI, CAP, GxP
- Serve as senior scientific/operational representative to clients and manage client relationships
🎯 Requirements
- D. in Immunology or a related scientific field
- 20 years of relevant experience, incl. 4+ years in industry and 12+ years as a functional manager
- Demonstrated leadership experience managing multi-functional laboratory teams
- Deep expertise in Companion Diagnostics, particularly within Cell and Gene Therapy
- Strong knowledge of FDA guidance and global regulatory frameworks (IVDR, ISO 13485/15189, CLIA)
- Proven experience developing and validating assays to support clinical studies
🎁 Benefits
- Discretionary annual bonus
- Health insurance
- Retirement savings benefits
- Life insurance and disability benefits
- Parental leave
- Paid time off for sick leave and vacation
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