Scientific Researcher and Development Lead
1 week ago
Direct Biologics is a pioneering company in the field of regenerative medical products, leveraging cutting-edge extracellular vesicle-based biologic platform technology. We strive to provide innovative solutions through rigorous research and scientific excellence.
**Estimated Annual Salary:** $120,000 - $180,000
The ideal candidate for this role will possess extensive knowledge of analytical method life cycle management, with a proven track record of success in late-stage to commercial cell-based assay validation. This individual should be well-versed in domestic and global regulatory requirements for analytical testing programs, with excellent scientific, communication, and time management skills.
Key Responsibilities:
- Develop and implement late-stage in-process and release analytical methods, ensuring compliance with regulatory requirements.
- Lead cross-functional initiatives to improve test methods, collaborate with R&D and QC personnel, and drive effective communication between stakeholders.
- Author technical documents, including method SOPs, development reports, qualification protocols/reports, and QBD risk assessments.
- Supervise method robustness, control strategy development, and validation at partner organizations.
Requirements:
- Bachelor's Degree in Cell Biology, Analytical Chemistry, or related field (Advanced degree preferred).
- Minimum 8 years of experience (or PhD + 4 years) developing analytical methods for biotechnology products and intermediates.
- Expertise in cell biology, inflammation, immunology, and autoimmunity.
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