• 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

What we’re looking for

• 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

What will separate you from the crowd

• 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

What you should know 

• Up to 10% travel is required
• Working in BSL-2 and BSL-2+ labs is required
• Occasional weekend work is required
• The base pay range for this position at commencement of employment is expected to be between $150,000 and $180,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience