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Using living cells to treat – and sometimes even cure – cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However, these profound results have not yet been achieved in patients with solid tumors, representing approximately 90% of all cancers. And for patients with hematologic malignancies, there is a need for next-generation cell therapies that can deliver increased response rates and longer duration of response.  We are a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. Lyell’s product candidates are enhanced with novel technology designed to generate T cells that resist exhaustion and have qualities of durable stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response. We were founded by cell therapy pioneers whose decades of research elevated the broader understanding of T-cell biology and its interaction with cancer. In our quest to advance next-generation CAR T-cell therapies, we have built a fully integrated company capable of discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients. Our culture is based on Science, Respect, Collaboration, and Courage and reflects who we are, the environment we create, and our mission's urgency.  This role will be based out of Bothell, Washington.

POSITION 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.

KEY ROLE AND 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.

PREFERRED EDUCATION & EXPERIENCE: 

• BA/BSc in biochemistry, chemical engineering, bioengineering, or related scientific field with a minimum of 15 years’ experience; or
• MBA or MSc in biochemistry, chemical engineering, bioengineering, or related scientific field with a minimum of 10 years’ experience
• Minimum 10 years’ experience in support of cell culture and upstream operations for GMP biopharmaceutical manufacturing with a minimum of 5 years’ experience
  supporting cell or gene therapy manufacturing.
• Experience in senior technical roles within a GMP biopharmaceutical manufacturing operation, 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 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.

 PHYSICAL 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. While performing their duties, the employee must be able to do the following:

• Confirm visual information in the environment such as batch record and SOP steps were completed properly, parameters on equipment and computer screens, status of materials and equipment and perform visual inspection of materials and product. A vision test may be required. Use of corrective lenses is acceptable. 
• Stand and step over a gowning bench (12-24”) and aseptically don head-to-toe non-sterile and sterile gowns.

 SHIFT WORK, WEEKEND WORK AND HOLIDAY COVERAGE:

Due to the nature of our autologous cell therapies and the need to deliver life-saving treatments to our patients as timely as possible, this leader will need to support staff on various shifts, weekends, and holidays as needed.