Specialist - Cell Therapy Manufacturing

About the Department                                                                                                                                     

Novo Nordisk, a global health care company, is committed to discovering and developing innovative medicines to help people living with diabetes lead longer, healthier lives. To support this, Novo Nordisk is conducting research on stem cell therapy. Stem cell research raises hopes for improved treatment of Type 1 Diabetes and for future treatments with cell transplantation therapy. This treatment could be offered to people with many different serious chronic diseases caused by the degeneration of specific cells, such as Type 1 Diabetes. Type 1 Diabetes is manifested by the selective destruction of the insulin-producing cells in the body, which leads to a life-long dependence on insulin injections to control blood sugar levels. It is usually diagnosed in children and young adults. Cell therapy may offer a better treatment by replacing the lost cells with new insulin-producing cells derived from stem cells, thus avoiding daily multiple insulin injections as well as numerous blood glucose tests. This treatment may also offer better blood glucose control, which is crucial to avoid late-stage complications such as blindness and kidney failure. In this project Novo Nordisk will generate new stem cell lines to be used in future cell therapies to treat Type 1 Diabetes, Parkinson’s and chronical heart failure.  Are you ready to make a difference?

 

The Position

Novo Nordisk, a global health care company, is committed to discovering and developing innovative medicines to help people living with diabetes lead longer, healthier lives. To support this, Novo Nordisk is conducting research in cell therapy which raises hopes for improved treatment of Type 1 Diabetes and other chronic diseases.

 

The Specialist will provide technical expertise and perform various tasks in a manufacturing environment in compliance with cGMP regulations. The Specialist will help in the development of new processes, organize and coordinate manufacturing activities, and train junior and newly hired personnel.

 

Relationships

The Specialist is an individual contributor and will work at the Cell Therapy R&D facility located in Fremont, Ca. The Specialist will report to a member of the Cell Therapy Leadership Team. Internal stakeholders include Cell Therapy in Novo Nordisk A/S (Denmark), Novo Nordisk Research Center Seattle, Inc. (NNRCSI) and Novo Nordisk Quality.

 

Essential Functions

• Organize, coordinate, and lead production activities and ensure execution of processes in production while strictly adhering to cGMP regulations, environmental health and safety guidelines, and any other related regulations which could apply
• Train staff in processing methods, aseptic technique, and cGMP clean room operations
• Write and/or revise master production records, SOPs, deviations, change requests, training materials, protocols, reports, and other required documentation
• Identify and troubleshoot technical issues with the process and equipment. Develop and implement corrective actions
• Produce cell therapy products using undifferentiated human embryonic stem cells in accordance with the manufacturing procedures, SOPs, and approved protocols in a full GTP and GMP compliant cleanroom environment including full aseptic gowning
• Provide support for commissioning and validation activities in addition to other facility start-up activities, as needed
• Review batch production records for completeness, accuracy, and to ensure cGMPs and Good Documentation Practices are followed
• Collaborate with cross-functional teams i.e., Quality, Facilities, Process Development
• Perform final derivation
• Perform additional job-related duties as required

 

Physical Requirements

Up to 10% overnight travel required. Ability to qualify to work in the cleanroom, up to Grade A requirements. Ability to lift 25 lbs. Ability to work outside of normal working hours as