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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 Associate Director of Validation, you will be responsible for supporting the production of cell therapy products for both global clinical trials and commercial supply at the Sana, Allo-T manufacturing facility in Bothell, WA. You will manage a validation team with a blend of internal and external resources focused on Validation.

Your focus areas will include site startup and delivery, periodic review/ongoing monitoring, process engineering, new technology introduction, asset validation, document control and aseptic & environmental control. The Associate Director of Validation oversees ad hoc teams performing validation activities, ensures the completion of all deliverables and develops the long-term strategy for validating and maintaining the validated state. Work will involve the use and management of validation document control and quality system software and applications (e.g. Kneat, Veeva, etc.), creating and driving validation strategies which align with corporate objectives (such as timelines and costs), project plans/planning and dashboards to drive accountability and delivery for the validation team. As Associate Director of Validation, you will report to the Sr. Director of Facilities and Engineering Site Startup.

What you’ll do

• Ownership of commissioning, qualification, and validation activities for the on-time delivery of a cell and gene therapy manufacturing facility in Bothell, WA
• Establish validation best practices, validation strategy, and maintenance/management of validation processes to achieve both GMP compliance and company goals and department objectives
• Lead team of validation engineers and specialists with varying levels of experience from entry level to senior/principal engineer
• Review and approve validation documentation ranging from risk assessments, system-level impact assessments, and trace matrices to IQ & OQ protocols
• Be accountable for all validation lifecycle activities for equipment (manufacturing and QC), facilities, and utilities including DQ/IQ/OQ/PQ, summary reports, validation deviations, change records, and periodic review
• Lead, develop, and implement site-specific master validation plans for the facility, utilities, and equipment
• Lead validation related activities during design, build, and/or modification of Sana’s manufacturing facility
• Maintain a constant state of inspection readiness by acting as the primary contact for internal and Health Authority audits and driving audit observation corrective actions to closure
• Influence and review technical content within the validation and facility sections of regulatory filings
• Quality record planning and execution (deviations, change controls, Corrective and Preventative Actions (CAPA))
• Work with IT validation partners (CSV) to implement computer-controlled equipment
• Support aseptic process simulation and environmental monitoring process qualification
• Qualify new technologies introduced to produce cell therapy products
• Collaborate with the Facilities & Engineering team, site stakeholders, to ensure engineering reliability
• Business Owner for electronic document control system (Kneat or similar)
• Identify, design, and implement process and system improvements within Commissioning, Qualification, and Validation
• Participates in Facilities and Engineering strategic meetings and be member of the F&E Leadership Team
• Contributes qualification/validation perspective to MSAT, IT, and other key stakeholders during implementation of new technologies and other strategic initiatives
• Motivate and mentor validation team members and enable their career growth
• Retain and develop key talent through timely performance discussions, annual performance evaluations, and individual career development plans

What we’re looking for

• BA or MS plus 8 yrs or equivalent combination of education and work experience; strong knowledge of required principals and concepts with understanding of context for application and deep subject matter expertise seen as emerging leader
• 8+ years of relevant experience in cGMP environment for Biologics/CMC/ Vaccines; 3+ years managing direct reports with varying levels of experience
• Proven record of successfully managing validation and engineering programs
• Thorough knowledge of validation life cycle including 21 CFR Parts 210, 211, 11, EU Annex 11, GAMP 5, and Data Integrity as well as ICH guidelines Q8, Q9, Q10
• Experience in multiple areas of validation including facilities, utilities, manufacturing, process, and/or QC laboratory equipment, software validation and data integrity, media fill/aseptic process simulation (APS), environmental monitoring performance qualification (EMPQ)
• Experience representing validation program(s) during internal as well as US- and international-specific health authority audits, particularly pre-licensure inspections (PLIs)
• Excellent organizational skills
• Excellent verbal and written communication skills
• Proficient in exercising sound judgment and flexibility while adapting to rapidly changing priorities, challenging situations, and deadlines needed to meet business objectives

What will separate you from the crowd

• Experience with cell therapies highly desired

What you should know

• The base pay range for this position at commencement of employment is expected to be between $160,000 and $200,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience