Ops Expert Facility Start-Up

What can you expect?   

To support the operational readiness, start-up, and long-term success of our Facility Start-up, we are looking for Ops (Jr/Sr) Expert who are excited to help build a new manufacturing capability from the ground up. In this role, you will be part of the Operational Core Team and contribute to facility readiness, technology transfer activities and the successful transition towards commercial manufacturing operations. As the facility start-up progresses towards clinical and commercial readiness, you will contribute to the creation and improvement of work instructions, SOPs, and practical workflows for personnel, materials, waste, and logistics management across the manufacturing areas.

Here's what you'll do:  

• You will support the startup and operational readiness of our manufacturing and GMP facility. This includes helping establish process flows, supporting cleanroom readiness, implementing 5S principles, and optimizing the storage of equipment and materials. You will work closely with cross-functional teams to build efficient operational processes from the ground up. 

• You will contribute to technology transfer activities and help prepare the facility for commercial manufacturing. You will support the development and improvement of work instructions, SOPs, Master Batch Records (MBRs), and operational workflows related to personnel, materials, waste, and logistics. 

• Once commercial readiness is achieved, you will perform daily manufacturing activities within a sterile cGMP environment. Depending on operational needs and your experience, you will support isolator-based operations, Grade C cell processing activities, or Grade A/B aseptic operations involved in manufacturing advanced cell therapies. 

• You will follow approved procedures, SOPs, batch records, and quality systems to ensure product quality, patient safety, and regulatory compliance. You will accurately complete GMP documentation and support quality activities such as deviations, investigations, CAPAs, and change controls when needed. 

• You will maintain GMP production areas by performing equipment cleaning, environmental monitoring, and facility-related activities in Grade B, C, and D cleanroom environments. You will also manage materials, consumables, and waste according to approved procedures. 

• You will actively contribute to process optimization, automation initiatives, and operational excellence projects. By observing floor operations and collaborating with stakeholders across the organization, you will help identify opportunities to improve efficiency, workflow design, and manufacturing readiness. 

• You will work closely with Manufacturing, MSAT, Quality, Engineering, Site Strategy & Excellence, Warehouse, Facility, IT, and other departments to ensure smooth operations and successful execution of manufacturing activities.