CMC Leads for I&D Center

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.

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 stability and compatibility data, product specification, manufacturing process, analytical methods, 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. You will also handle deviation errands, risk assessments and root cause investigations to ascertain product quality. Moreover, you are involved in responding to authority requests.

About you

You have an academic background in pharmaceutical sciences, formulation science, analytical chemistry, or equivalent. It is required that you are familiar with the drug development process and have preferably 5+ years of experience from pharmaceutical development work within the life science industry, including knowledge about the regulatory framework of CMC submissions. Experience within project management and formulation development (e.g. emulsion expertise) is a merit.

As CMC Lead you are the spider in the web and handle many internal and external contacts on different organizational levels. You are striving to build professional relationships and like networking. You will make good use of your problem-solving skills and work in a goal-oriented manner to achieve win-win results. Furthermore, you enjoy collaborating with colleagues and external partners to reach common goals, and have excellent communication skills. Good knowledge of the English language, both orally and in writing, is a must. The tasks also imply that you have excellent planning skills, develop and convey the overall picture, monitor progress, and respond to changes quickly.

About the role

The position is initially a temporary employment with a view to become permanent employment if both parts agree after 6 months. The position is placed in Uppsala.

 

About us

We are a growing company with about 1100 employees in Sweden, and over 37 000 employees worldwide. We are proud of our products and that can be noticed throughout the whole company. In our employee survey the colleagues, the development opportunities and the familiar atmosphere are mentioned as some of the best parts about working at Fresenius Kabi. 

 

Being a part of Fresenius Kabi means being a part of an environment with a strong prospect. We believe in our employees and we are passionate about the development of every individual. Our global extent gives you a great opportunity to select your own future development path.

 

Contact
If you want to know more about this role, please contact Anna Lundquist, Director Formulation Development PN, +46 73 270 1824. Union representatives are Frank Glackin for Unionen, 018 644 773 and Teresia Karlsson for SACO, 018–644 034.

 

We look forward to your application! Selection and interviews will be ongoing during the whole application period, so please register your application in English as soon as possible.
We do not accept applications by e-mail or post.