Director, MSAT

Role Summary

Director, MSAT at Lyell. Lead the Manufacturing Science and Technology group responsible for manufacturing technical oversight of viral vector and cell therapies for clinical trials. Based in Bothell, Washington.

Responsibilities

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

Qualifications

• BA/BSc in biochemistry, chemical engineering, bioengineering, or related scientific field with a minimum of 15 years‚Äô experience; or MBA or MSc with a minimum of 10 years‚Äô experience.
• Minimum 10 years‚Äô experience in support of cell culture and upstream operations for GMP biopharmaceutical manufacturing with at least 5 years supporting 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 (e.g., Deviations, CAPAs, Change Management).

Knowledge, Skills and Abilities

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

Physical Requirements

• Ability to confirm visual information in the environment (batch records, SOP steps, equipment status, materials) and perform visual inspection; vision test may be required; corrective lenses permitted.
• Stand and maneuver around gowning benches and don appropriate gowns.

Additional Requirements

• Shift work, weekend work, and holiday coverage as needed due to operating needs of autologous cell therapies.