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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. We have a fantastic opportunity for an experienced, dynamic leader to join our growing Quality team within Technical Operations. The Executive Director, Head of Corporate Quality Control (QC) is responsible for establishing and leading the corporate QC policies, strategies, method transfers, method qualifications/validations, and testing operations at the Sana South San Francisco site. Additionally, the leader will manage contracted external testing sites to ensure the work is efficient, on time, on budget, and executed with highest quality as well as, driving continuous improvement initiatives to maintain compliance with regulatory requirements.

What you’ll do

• Provide strategic direction and leadership to the Corporate QC function and implementation of CMC control strategies, including environmental monitoring & microbial controls, raw materials testing, compendial testing, in-process testing, release and stability testing of cell and gene therapy products
• Ensure instrument and software qualification, exemplary QC data integrity, secure sample management, and effective QC document management
• Establish and manage collaborative relationships with key internal and external stakeholders including Contract Manufacturing Organizations (CMOs) and contract testing laboratories
• Direct phase-appropriate assay transfer, assay qualification, and validation activities
• Ensure timely and accurate release of starting materials, raw materials, drug substances and drug products to support clinical/commercial activities
• Collaborate with other Tech Ops stakeholders in Process and Analytical development, Quality and Regulatory to set appropriate product specifications, develop comparability strategies and support manufacturing investigations
• Support and follow on with critical technical Out Of Specifications (OOS) /Trend (OOT) Investigations
• Author and review relevant sections of CMC documentation in support of INDs, CTAs, BLA submissions, amendments, and briefing documents
• Participate in internal and external audits and ensure timely closure of audit findings
• Provide servant leadership to the QC team, including hiring, mentoring, career progression and developing staff members to ensure projects are adequately staffed
• Interface with Analytical Development, Quality Assurance, Process Development, CMC and Project Management, and Technical Operations Teams to advance Sana Portfolio to complete milestones within timelines
• Monitor industry trends and emerging technologies to identify opportunities for improvement in quality control business processes.
• Establish and maintain effective relationships with regulatory authorities, customers, and suppliers to ensure compliance with regulatory requirements and customer expectations.
• Manage and oversee the identification, procurement, installation, and maintenance of all critical laboratory equipment
• Contribute to Quality budget planning and approve proposed budgets for supporting teams and sub-functions
• Make sound decisions regarding complex technical issues and communicate decisions effectively with internal stakeholders, elevating complex issues as appropriate
• Communicate with facts, clarity, and authenticity up, down, and across organizations.
• 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

• PhD in Chemistry, Biology, Bioengineering or related field with 10-15+ years of relevant industry experience. BA and/or MS with equivalent combination of education and work experience are considered
• 7-10+ years of managing GMP functions, vendor relations and technical professionals
• Expertise in phase appropriate GMP testing, and Lab Operations of cell therapies or biologics
• Expertise in qualification, validation, transfer and life cycle management of analytical methods
• Experience in Health Authority Inspections, related observations and implementation of CAPAs
• Proven record of highly developed communications (verbal and written), and ability to navigate highly collaborative workstreams with internal and external stakeholder
• Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines with excellent time management and organizational skills
• Proven track-record to collaborate effectively in a cross-functional matrix environment and lead with curiosity and influence across functional and organizational lines
• Ability to effectively work through change and ambiguity
• Ability to engage in crucial conversations – providing and receiving feedback

What you should know

• Working safely in person on a predictable and regular basis is an essential job function for this position, and the Company requires that all individuals working in-person be fully vaccinated against COVID-19
• The base pay range for this position at commencement of employment is expected to be between $260,000 and $320,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience