Scientific Researcher and Development Lead

1 week ago


Poway, California, United States Direct Biologics Full time

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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