Scientific Manager for Critical Reagents and Sample Testing
1 week ago
We are seeking an experienced Scientific Manager to oversee critical reagents related to lot release assays and provide sample testing support for Analytical and/or Microbiological quality control testing of products, raw materials, and investigations.
Key Responsibilities- Critical Reagent Management: Ensure positive controls and other critical reagents are qualified in compliance with cGMP/FDA regulations, Iovance standard operating procedures, and policies.
- Sample Testing Support: Provide expertise in quality control compliance and technical writing skills to ensure robust analytical methods and commercial testing requirements.
- Method Qualification and Lifecycle Management: Develop and implement qualification methods for critical reagents and manage their lifecycle.
- Bachelor's degree in biology, biochemistry, microbiology, chemistry, or a related scientific field.
- 6-8 years of industry experience, preferably in cell therapy products.
- Strong understanding of Flow Cytometry, Cell-based ELISA, cell culture, and molecular assays.
- Excellent communication and technical writing skills.
- Ability to effectively manage multiple priorities and work in a team environment.
The estimated salary range for this position is $120,000 - $180,000 per year, depending on experience.
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