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Senior Director Gene Editing Technologies
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$240,000 - $290,000 a year
Full-time
- As a Senior Director Gene Editing Technologies within the Analytical Development department, you will report to the Vice President Head of Analytical Development and lead a function accountable for establishing deep characterization and knowledge of gene editing technologies used in the manufacture Sana’s cell therapy products.
- Define and support the implementation of CQdriven analytical strategies, oversee analytical method development, qualification, validation and Tech Transfer of lot release, stability, in-process and characterization methods for a diverse range of RNA platforms both in-house and at CMOs/CROs/CTLs.
- In this role, you will be accountable for establishing science-driven, phase appropriate, and risk-based analytical development and control strategies to support cell therapy programs from clinical development to commercial registration
- Collaborate with Regulatory Affairs to author and review relevant sections of CMC documentation in support of INDs, including pre-IND meeting briefing documents, CTAs, BLA; comparability plans and reports
- Significant experience with CMC drug development, specifically cell and gene therapy programs particularly in development of gene edited cellular therapy programs
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