Principal Scientist, Gene Editing Process Development and Tech Transfer

As a Principal Scientist, Gene Editing Process Development & Tech Transfer at Sana Biotechnology, you will lead and manage the development, optimization, and scale-up of processes for the production of gene editing reagents. Your role will involve working with cross-functional teams to ensure successful tech transfer, GMP production, and release of gene editing reagents. Additionally, you will contribute to CMC regulatory activities and the overall gene editing CMC strategy. This position requires technical expertise in gene editing processes and manufacturing, as well as experience in a regulated environment.

• Lead and manage CDMO's development, optimization, and scale-up of processes for the production of gene editing reagents
• Lead internal and external cross-functional teams for successful tech transfer, GMP production, and release of gene editing reagents
• Support due diligence of CDMOs and gene editing technologies
• Participate in CMC regulatory activities, including filing and health authority interactions
• Contribute to the gene editing CMC strategy along with other CMC functions
• Manage the translation of research and development programs to GMP manufacturing
• Technical expertise in processes and manufacturing of gene editing reagents
• Experience in process and analytical development, tech transfer, manufacturing under cGMP, and process comparability in a regulated environment
• Experience with different modalities of genetically modified cell & gene therapies
• Understanding of the state of the art in global regulatory perspectives on gene editing, as well as analytical methods and bioinformatic tools in the space are highly desirable
• Experience in process characterization and validation preferred
• Up to 20% travel to CDMOs and other Sana locations

• BS/BA in molecular biology, genetics biotechnology, or related discipline with 10+ years OR MS/MA with 8+ years OR PhD with 5+ years in gene editing experience
• Technical expertise in processes and manufacturing of gene editing reagents, including but not limited to mRNA, sgRNA, DNA template, nucleases, and relevant analytical methods
• Experience in process and analytical development, tech transfer, manufacturing under cGMP, and process comparability in a regulated environment
• Experience with different modalities of genetically modified cell & gene therapies
• Understanding of the state of the art in global regulatory perspectives on gene editing, as well as analytical methods and bioinformatic tools in the space are highly desirable
• Experience in process characterization and validation preferred
• Up to 20% travel to CDMOs and other Sana locations

• 100% coverage of employee health coverage
• Generous time-off benefits (holidays, vacation, sick time, and parental leave)
• Short- and long-term disability coverage
• Employer paid basic life insurance
• Additional voluntary life insurance protection
• Financial wellness programs including financial planning resources
• 401(k) Plan with an immediately vested employer match
• Tuition Reimbursement and Student Loan Repayment
• Employee Stock Purchase Plan
• Commuter subsidy
• Variety of wellness offerings to support each person individually