GE HealthCare is looking for a Manufacturing Scientist

Job Description 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 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 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.

Essential Responsibilities

·       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.

·       Optimize existing product preparation processes by using current control systems to achieve automated, lean and robust processes in compliance with Good Manufacturing Practice (GMP)

·       Working with Engineering team and vendors to design machinery to ensure equipment is fit for purpose

·       Support formulation work from a technical point of view, internally or in collaboration with R&D and external parties.

·       Ensure technical solutions suitable for Drug Product formulations, processes, materials and equipment to correct level of quality, specifications and controls in cooperation with R&D and commercial production sites.

·       Produce and review suitable scientific reports & documentation to support regulatory documentation packages (IND's, IMPD’s, NDA, MAA, etc).

Qualifications/Requirements

·       PhD/MSc in Engineering, Cybernetics, Process Control, Electronic, Technical pharmaceutic or similar

·       Ability to understand and work with complex combinations of process equipment including process control 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 design tools, e.g. Visio and statistical tools

Desired Characteristics/Skills

·       Experience from production of Pharmaceuticals or related Industry

·       Ability to work on a strategic level as well as on a practical level /hands on to develop production processes

·       Interest in technology to find best solutions for running and controlling a production process

·       Experienced with Good Manufacturing Practice requirements

·       Builds wide and effective networks of contacts inside and outside the organization

·       Experience with developing pharmaceutical products will be beneficial