Fresenius Kabi AB
Fresenius Kabi is a global health care company that specializes in lifesaving medicines and medical technologies for infusion, transfusion and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. We are part of Fresenius SE, a health care group with more than 100 years of experience in pharmaceuticals, medical devices and life sciences. Our employees – more than 35,000 worldwide – develop and deliver injectable pharmaceuticals and infusion systems; blood collection, transfusion and cell technologies; and essential nutrients for parenteral nutrition. 

Whether you work for us, buy from us, partner with us, or invest in us, you will come to know that caring is at the core of everything we do. Our purpose is to put lifesaving medicines and technologies in the hands of people who care for patients, and to find answers to the challenges they face every day.

CMC Leads for I&D Center
Fresenius Kabi is the market leader in parenteral nutrition focused on improving patient care. The Innovation & Development (I&D) Center Sweden is a part of the global development organization of Fresenius Kabi and is responsible for the development of parenteral nutrition products such as amino acid solutions, lipid emulsions, and micro-nutrients products. The Center is located in Uppsala, and consists of approximately 30 employees working mainly within Analytical Development and Formulation Development of parenteral nutrition products. We are now looking for two qualified and experienced CMC Leads to expand our organization.

Main tasks
The CMC Lead is a key role within Fresenius Kabi as it sets product development strategy to enable execution of Chemistry, Manufacturing, and Controls (CMC) activities throughout a product's lifecycle. As CMC Lead you work cross-functionally in an international organization, in close collaboration with colleagues in, e.g., Germany, Austria, China and USA. 

Your task is to manage and coordinate the CMC part of international development projects within parenteral nutrition in order to ensure delivery of project results on time, on budget and according to the agreed Target Product Profile (TPP). For each project, there is a dedicated project group consisting of the various expert team members, headed by a professional project manager. As the CMC expert, you are accountable for the CMC deliverables, such as analytical methods, stability and compatibility data, product formulation, manufacturing process, clinical trials material, technology transfer to the manufacturing site, and writing of regulatory CMC documents for submission to international healthcare authorities. A considerable part of your work will consist of planning, conducting and evaluation of product development studies, e.g. formulation development or analytical method development. If needed, you assist in handling of deviations and change control errands. Moreover, you are involved in responding to authority requests.

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CMC Leads for I&D Center

Fresenius Kabi AB

Kategori: Forskning / R&D / Vetenskap
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