Senior Operations Scientist, Quality Control

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 Sr. Operations Scientist, Quality Control, you will report to Head of Corporate Quality Control, and will help build out the corporate QC function, support assay transfer and qualification activities, and support the raw materials qualification program.

Roles and Responsibilities 

• Serve as the QC Subject Matter Expert (SME) for compendial requirements, raw materials testing, analytical methods, sampling, stability, and investigations to support Sana’s cell therapy programs.
• Support material qualification program including raw materials risk assessments.
• Partner with Analytical Development to ensure analytical methods are successfully transferred to QC.
• Manage method optimization, transfer, qualification, or validation activities for Sana QC laboratories.
• Establish QC business process and procedures including product specification generation for batch release of Sana’s critical raw materials and drug products.
• Support the QC laboratory and GMP testing readiness.
• Support deviations, OOS, change control, investigations, and CAPAs.
• Support the review and authoring of regulatory filing activities.
• Collaborate with other Tech Ops partners in analytical, process development, quality and regulatory to support establishment of control systems, set appropriate product specifications, develop comparability strategies, and support manufacturing investigations.
• Collaborate with Manufacturing, QA, and Process Development teams to evaluate and investigate issues.

Qualification and Experience

• PhD in Cell Biology, Molecular Biology, Immunology, or a related scientific discipline w 5+ yrs experience in academic research and/or industry. BA or MS plus 8+ yrs or equivalent combination of education and work experience.
• Deep subject matter expertise in Quality Control. You will have demonstrated experience, leadership, and independence with QC functions associated with the GMP production and testing of cell/gene therapy products or biologics in both clinical and/or commercial settings.
• Experience managing a raw material qualification program.
• Experience in performing phase-appropriate assay qualification/validation in a GLP or GMP environment.
• Experience in transferring assays from internal AD to QC teams and externally to a CDMO.
• Knowledge and understanding of regulatory guidelines from the FDA, ICH, USP, EP, etc.
• Excellent written and oral communication skills.
• Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment.
• Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues.
• Goal oriented with the ability to troubleshoot and resolve problems.
• Successful track record of developing cooperative, productive relationships across all functions with people at all levels within and external to the organization.
• High degree of self-motivation.

Preferred 

• Experience at a startup or pre-clinical biotechnology company; cell or gene therapy experience is a plus.
• Technical expertise in any of the following areas: multi-color flow cytometry assays, cell-based assays for potency, viral titer assays, or molecular assays utilizing ddPCR and/or qPCR.