Director, MSAT

Role Summary

The individual in this role will be responsible for leading the Manufacturing Science and Technology group that is responsible for manufacturing technical oversight of viral vector and cell therapies for clinical trials. As part of the Site Leadership team, this role is responsible for technology transfers into manufacturing, and critical manufacturing support activities including investigations, change controls, CAPAs, data management, process capability, process capacity, process efficiency and process quality improvements. This role will be based out of 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 (1) impact to quality and (2) delays to availability of the lifesaving therapies.
• Maintain role as Manufacturing Execution System (MES) business owner and provide leadership / sponsorship 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 as necessary sections of the 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 the new product and process introduction risk assessment, tech transfer documents, protocols and reports, project plan deliverables and change controls.
• Ensure technical support for deviation management, lot disposition, batch record reviews so that technical issues stay off the critical path for reliable supply.
• Partner with GMP Systems to ensure recipes are designed, tested, and ready for use.
• Continue to refine the tech transfer process to ensure there is a clear understanding of the business process and clear roles and responsibilities.
• Provide technical guidance to the MSAT team and cross-functional project teams in areas of facility fit, gap analysis, FMEA risk assessment, troubleshooting and investigation.
• 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 behaviors, provide guidance and direction through the performance management process to develop and reward staff.

Qualifications

• Preferred: BA/BSc in biochemistry, chemical engineering, bioengineering, or related scientific field with a minimum of 15 years’ experience; or
• Preferred: MBA or MSc in biochemistry, chemical engineering, bioengineering, or related scientific field with a minimum of 10 years’ experience
• Preferred: Minimum 10 years’ experience in support of cell culture and upstream operations for GMP biopharmaceutical manufacturing with a minimum of 5 years’ experience
• Preferred: Supporting cell or gene therapy manufacturing.
• Preferred: Experience in senior technical roles within a GMP biopharmaceutical manufacturing operation, leading and managing staff.
• Preferred: Experience with manufacturing automation, MES, and lab information systems.
• Preferred: Experience with quality management systems (e.g. Deviations, CAPAs, Change Management).

Skills

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

Education

• BA/BSc in biochemistry, chemical engineering, bioengineering, or related scientific field.
• MBA or MSc in biochemistry, chemical engineering, bioengineering, or related scientific field.

Additional Requirements

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job