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Specialist, Manufacturing Execution System

Bothell, Washington, United States

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.

KEY ROLE AND RESPONSIBILITIES:

Lyell is operating a state-of-the-art immunotherapy manufacturing facility with advanced system automation and data integration to enable the production and delivery of our cell therapy to cancer patients. We are looking for a forward-thinking MES Specialist to join our GMP Systems
and Data Management team. The MES Specialist will be responsible for supporting the manufacturing execution system (MES) and electronic Master Batch Records (MBRs). This role will also provide MES system support to Manufacturing, MSAT, Technical Transfer,Quality and Supply Chain to ensure priorities are being addressed in a timely manner to meet Lyell’s clinical programs timeline. The successful candidate will have experience in a regulated biotech or pharmaceutical setting.

KEY RESPONSIBILITIES:
- Design, develop, validate and support where needed for the manufacturing execution system.
- Collaborate with cross-functional teams to outline process requirements and develop manufacturing batch records (recipes) encompassing:
operational data and workflows, Critical calculations and process parameters, and other related configurations
- Configure and maintain MES master data required for the execution of the manufacturing batch records that support GMP operations.
- Maintain overall system compliance by updating relevant documentation including standard operating procedures (SOPs,) specifications, functional testing and end user training.
- Manage security profiles and user’s accounts.
- Provide MES support for production that includes hours outside of normal business hours, which is a 4–10-hour day schedule, Sunday through Wednesday. (On call support is required for weekends, holidays, and evenings).
- Support the development and optimization of manufacturing processes through close collaboration with MSAT.
Configure/update MES to support new clinical programs and process versions as
needed.

SKILLS AND REQUIREMENTS: 

  • Minimum of 5 years of GMP manufacturing and operations experience, direct experience with MES is a plus.
  • Experience with design and deployment of MBRs in a Manufacturing Execution Systems.
  • Bachelor’s degree or higher in engineering, computer science or equivalent technical skills
  • Working in a fast paced, and sometimes ambiguous environment
  • Excellent communication, project management and technical writing
  • Proven critical thinker with strong logical and analytical skills 
  • Team-oriented 
  • Willingness to expand knowledge to other GxP systems other than MES, such as Laboratory Information Management Systems (LIMS) and Enterprise Resource Planning (ERP) 
  • Experience in cell therapy or biologics manufacturing unit operations such as cell processing, aseptic processing, fill/finish strongly preferred 
  • Deep understanding of Master Batch Record design with formal training and experience 
  • Ability to define and manage master data within computer systems, such as MES

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