External Quality Control Principal Research Associate

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 are passionate about delivering the possible to patients, and who lead with the desire to work on novel ideas. As an External Quality Control Principal Research Associate, you will report to the Senior Director, Analytical Development and Quality Control.

You will support a wide variety of analytical methods for Sana’s cell therapy products while working with a cross-functional team on method development, transfer, and qualification, providing onsite training and technical support at CDMO, and overseeing contract test labs to enable drug product release. This role is onsite in South San Francisco, CA.

• Collaborate with the Analytical Transfer Lead to transfer release methods to contract development and manufacturing organization (CDMO) and provide onsite training and technical support to enable GMP implementation
• Assist with the coordination of QC activities at CDMO and contract test labs (CTLs), including providing technical guidance on troubleshooting and participating in data review
• Work with method developers and external partners to design and execute studies supporting method development, transfer, and qualification
• Perform routine release, characterization, and stability testing and document testing according to Good Documentation Practices and GMP data integrity requirements as appropriate
• Work cross-functionally with Process Development, MSAT, Quality Assurance, and other departments to optimize sampling plan, analytical testing, product specifications, and process control strategies
• Author, review, and approve method qualification protocols and reports
• Own or contribute to change controls, investigations, and CAPAs
• Support the authoring and maintenance of product specifications, test methods, sampling plans, certificates of analysis, and stability study reports
• Assist in developing quality systems, establishing SOPs, work instructions, and other procedures to support QC operations
• Manage laboratory equipment and software through installation, qualification, maintenance, and retirement

• S. or M.S. in Cell Biology, Immunology, or a related scientific discipline with 5-6 years related work experience
• Experience developing, optimizing, and qualifying multi-color flow cytometry methods according to ICH guidelines and performing data analysis independently with minimal guidance
• Experience transferring analytical methods to CDMOs CTLs and overseeing GMP implementation
• Experience authoring and/or reviewing SOPs, test methods, and other quality-related documents
• Strong knowledge of GMP requirements and regulations
• Strong knowledge of GMP testing and quality systems
• Experience with change controls, deviations, and CAPAs
• Ability to work in a dynamic environment to deliver on-time project completion with tight timelines

• Experience supporting the rapid release of cell therapy products in a GMP environment
• Experience implementing rapid safety test methods (e.g. BACT/ALERT for sterility and BIOFIRE for mycoplasma) in place of conventional methods
• Experience using statistical software such as JMP for DOE, data visualization, and analysis

• Travel to CDMO to provide onsite training and technical support is required
• There may be potential exposure to BSL2 and BSL2+ biohazard materials
• Occasional off-hours or weekend work may be required
• Physical Demands: standing, walking, and sitting for extended periods of time; frequent use of the hands, fingers, wrist, and greater arm to handle small materials, tools, boxes, and trays; lifting and carrying objects up to 10 lbs; occasional overhead reaches and lifts; occasional lifts and reaches below the knee; occasional pushing and pulling of materials and objects with moderate forces; occasional crouching/kneeling, twisting, and squatting movements
• Must be able to successfully pass all job-related tests and certifications required for working in a cGMP, quality environment including but not limited to inspections and GMP requirements to perform…