Senior Development Scientist in Regenerative Medicine
1 week ago
We are seeking a talented Senior Development Scientist to lead late-stage in-process and release analytical method development and validation. This is a fantastic opportunity to make an impact by driving key initiatives in analytical method lifecycle management, with a particular focus on cell-based potency assays.
As a scientific and strategic leader, you will collaborate with cross-functional teams, lead assay control strategies, and ensure the smooth transfer and validation of analytical methods at partner organizations.
Key Responsibilities:
- Develop, validate, and manage analytical methods for late-stage and commercial programs.
- Oversee assay control strategies with a focus on cell-based potency methods.
- Collaborate with R&D and QC teams to improve test methods and troubleshoot issues.
- Author key technical documents such as SOPs, development reports, and risk assessments.
- Lead analytical method transfer and validation activities at partner organizations.
- Ensure regulatory compliance and prepare for health authority interactions.
Qualifications:
- Bachelor's degree in Cell Biology, Analytical Chemistry, or a related field; advanced degree preferred.
- 8+ years of experience in developing analytical methods for biotechnology products, or 4+ years with a PhD.
- Expertise in cell biology, inflammation, and immunology, particularly in regenerative medicine.
- Proven success in managing late-stage to commercial analytical method validation and transfer.
- Strong communication skills and experience in cross-functional leadership.
The estimated annual salary for this position is approximately $120,000-$180,000, depending on qualifications and experience. Located in Poway, CA, this role offers a unique opportunity to drive innovation in the regenerative medicine space.
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