Director, MSAT

Role Summary

Director, MSAT based in Bothell, Washington. Leads the Manufacturing Science and Technology group responsible for manufacturing technical oversight of viral vector and cell therapies for clinical trials, including technology transfers, investigations, CAPAs, data management, and process improvements.

Responsibilities

• Optimize the MSAT process support model to ensure all Manufacturing operations are supported.
• Rapidly respond to technical issues encountered during production to minimize impact to quality and delays to therapy availability.
• Maintain MES as a business owner and provide leadership to cross-functional recipe teams.
• Build and maintain relationships with Quality to ensure compliant manufacturing, transfers, and changes.
• Assemble cross-functional stakeholders to build detailed project plans to achieve program goals.
• Oversee documentation and implementation of changes to manufacturing processes and MES recipes.
• Review and approve validation plans, protocols, and reports as necessary.
• Author/review/approve regulatory sections and communications to government authorities as needed.
• Serve as a technical resource for strategies, programs, and procedures.
• Ensure transfer requirements are met, including risk assessments, tech transfer documents, protocols, reports, project plans, and change controls.
• Provide technical support for deviation management, lot disposition, and batch record reviews to keep issues off the critical path.
• Partner with GMP Systems to ensure recipes are designed and ready for use.
• Refine the tech transfer process with clear roles and responsibilities.
• Provide technical guidance to the MSAT team and cross-functional project teams in facility fit, FMEA risk assessment, troubleshooting, and investigation.
• Support data acquisition and analysis for process/product insights.
• Identify opportunities for operational excellence and continuous improvement.
• Hire, train, and mentor MSAT staff; model leadership behaviors and manage performance to develop and reward staff.

Qualifications

• BA/BSc in biochemistry, chemical engineering, bioengineering, or related field with 15+ years of experience; or
• MBA or MSc in biochemistry, chemical engineering, bioengineering, or related field with 10+ years of experience.
• Minimum 10 years‚Äô experience in cell culture and upstream operations for GMP biopharmaceutical manufacturing, with at least 5 years in cell or gene therapy manufacturing.
• Experience in senior technical roles within GMP biopharmaceutical manufacturing, leading and managing staff.
• Experience with manufacturing automation, MES, and lab information systems.
• Experience with quality management systems (Deviations, CAPAs, Change Management).

Knowledge, Skills and Abilities

• Working knowledge of USA and global GMP regulations for drug substances/products and cellular/gene therapies, including phase-appropriate validation/qualification.
• Strong leadership, collaboration, and influencing skills; ability to problem-solve and drive change.
• Proven ability to lead and participate effectively on teams.
• Excellent written and verbal communication skills.

Physical Requirements

• Ability to confirm visual information, perform visual inspections, and be able to pass a vision test if required; corrective lenses allowed.
• Stand and maneuver around gowning benches and don appropriate gowns.

Additional Requirements

Shift, weekend, and holiday coverage as needed to support autologous cell therapies and timely delivery of treatments.