Senior Director Gene Editing Technologies

 About the role

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas.  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. The position will also assume a key leadership role in the establishment of CMC control strategies for Sana’s pipeline.

What you’ll do

• Provide strategic direction and oversight to ensure the implementation of state-of-the-art analytical technologies for RNA-based gene editing platforms from pre-clinical to commercial stages
• Define and support the implementation of CQA-driven 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
• Partner with Research, Tech Sciences, Process Development and Clinical teams to design characterization strategies that inform understanding regarding the impact of gene editing on cellular biology, including heterogeneity and function, to identify and justify critical quality
• Serve as the Analytical Lead for cross-functional teams. 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
• Serve as Subject Matter Expert for GMP critical reagent supply and vendor selection, ensuring high-quality materials and strong partnerships with suppliers
• Lead and support investigations for Out of Specification, and Out of Trend results, as well as Change Control, Deviations, and Corrective and Preventive Actions (CAPAs), ensuring timely resolution and continuous improvement
• Support the implementation of manufacturing process changes at CDMO, specifically for gene editing reagents, to ensure a smooth and successful development. Provide input to in-process characterization and analytical testing support for upstream, downstream, and formulation processes
• 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
• Work with Tech Ops stakeholders in AD/PD, Quality and Regulatory to set appropriate specifications, develop comparability strategies and support manufacturing investigations. Establish regular interface and build strong connections with CMOs and contract labs
• Make sound decisions regarding complex technical issues and communicate decisions effectively with internal stakeholders, elevating complex issues as appropriate
• Collaborate with internal and external stakeholders including health authorities and industry organizations to identify trends and expectations and incorporate them into Sana’s CMC control strategies
• Engage in crucial conversations by providing and receiving feedback supporting the growth and development of team members
• Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
• Drive curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment
• Innate ability to assess talent that will help grow the organization and add to Sana’s culture

What we’re looking for

• B.Sc. in Immunology, Cell Biology, or other related disciplines and 12+ years of experience in the Pharmaceutical Industry or equivalent combination of education and work experience, including 5+ years of experience in adoptive T-Cell based therapies.
• Significant experience with CMC drug development, specifically cell and gene therapy programs particularly in development of gene edited cellular therapy programs.
• Significant experience driving characterization of gene edited cellular therapy products to advance product understanding, process development and the establishment of control strategies.
• Significant hands-on experience with advanced analytical platforms i.e. biophysical techniques including Capillary Electrophoresis, HPLC-based platforms, Mass Spectrometry and related data analysis.
• Strong working knowledge and interpretation of FDA/EMA and ICH regulations and guidelines.
• Experience with testing support for GL