Specialist, Manufacturing Execution System

Specialist, Manufacturing Execution System

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.

Position Summary:

The individual in this role will be responsible for implementing and supporting the Manufacturing Execution System (MES) and electronic Master Batch Records (MBRs) strategy. This role provides MES system support to Manufacturing, MSAT, Technical Transfer, Quality and Supply Chain to ensure priorities are being addressed in a timely manner to meet the company’s clinical programs timeline.

• Continue to advance strategy for manufacturing documentation, including standard content and structure for batch records, standard operating procedures, forms, and
• Lead cross‑functional teams to develop manufacturing batch records, recipes, workflows, and standard operating procedures, ensuring that operational data, configurations, processes and reports meet all regulatory requirements.
• Support the system owner to lead and provide support in the design, development, and qualification of manufacturing execution systems.
• Ensure data integrity of various shop floor electronic systems utilizing MES where
• Support the roll out of MES software by creating relevant documentation, end‑user training and managing user accounts.
• Collaborate with internal business partners on priorities, timelines and transparent sharing of information.
• Design, implement, and test MES based on the Business process.
• Provide MES support for production that includes hours outside of normal business.
• Implement and maintain LIMS interactions and calculations, QMS for deviation generation during the process, and interface with ERP system to issue materials to MBRs that are acceptable & released.
• Support the development and optimization of manufacturing
• Configure/update MES to support new clinical programs and change
• Coordinate the review and revisions of procedures, Process Development/Technical Transfer documentation and FDA regulations for inclusion in SOP and quality.
• Responsible for ensuring compliance with Federal, State and local regulations and alignment to company policies and procedures relating to GMP’s, Health, Safety & Environmental Protection.

• BA/BSc in biology, biochemistry, chemical engineering, bioengineering, or related scientific field with a minimum of 5 years’ experience; or
• MBA or MSc in biology, biochemistry, chemical engineering, bioengineering, or related scientific field with a minimum of 3 years’ experience.

• Minimum 2 years’ experience in GMP manufacturing and operations experience with emphasis on MES deployment.
• Experience in Manufacturing Execution Systems primarily in having designed and created best practice MBRs.
• Experience with…