About Us: The Manufacturing Development, Technical Operations team is part of the Core Imaging Supply Chain, Life Sciences, GE Healthcare, and is operating in close contact with GEHC’s Marketing and R&D functions as well as keeping a close contact with our various production units. Key business areas within Core Imaging are neurology, oncology and cardiology, where GE Healthcare provides contrast agents and molecular imaging products across the imaging modalities X-Ray, MRI, Ultrasound, SPECT and PET. The products span across simple aqueous solutions, gas bubbles, cassette-based products and freeze-dried formulations. The drug products are for i.v. injection, so sterility assurance and adequate microbiological controls of all materials is a critical part of our work.
GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
Role Summary: The Manufacturing Scientist is an integral part of the Manufacturing Development, Technical Operations team which is responsible for developing (normally in co-operation with our R&D function), scaling up and delivering products ready for commercialization and giving support to our life cycle products as needed.
The Manufacturing Scientist’s role is to develop robust production processes, scalable to pre-clinical and clinical studies, and all the way up to and including commercial manufacturing. This work may include formulation work internally or in collaboration with R&D and external parties
Ensure suitable Drug Product formulations, processes, materials and equipment to correct level of quality, specifications and controls. The work will include practical work, specifically related to key process steps and equipment, e.g. freeze driers and sterilizers
Provide drug product formulation and process expertise to support R&D and Supply Chain projects in development as well as to marketed products (i.e. regulatory questions, set up of manufacturing)
Produce and review suitable scientific reports & documentation to support regulatory documentation packages (IND's, IMPD’s, NDA, MAA, etc)
PhD/MSc in Engineering, Pharmaceutics or similar
Ability to understand and work with complex combinations of process equipment and chemical substances processed through this equipment.
Strong scientific capability, clear thinking, ability to identify smart ways of working
Self-motivated and ability to work independently and as part of a team
Demonstrates good team working skills and working with people across cultures
Strong oral and written communication skills
English & Norwegian fluent verbal and written
Experienced in standard office tools like Word, Excel, PowerPoint etc.
Knowledge/experience in working with process desing tools, e.g. Visio and statistical tools
Experience from Pharmaceutical Industry or Regulatory Body
Experienced with Good Manufacturing Practice requirements
Builds wide and effective networks of contacts inside and outside the organization
Experience with developing pharmaceutical products
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