Chemistry, Manufacturing and Controls (CMC) Lead 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.

Are you looking for the next career step in product development of one of the leading pharmaceutical companies? Then look no further – Fresenius Kabi is the right place for you .

The Innovation & Development (I&D) Center Sweden within the Pharmaceuticals & Devices Division 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.


 

Your assignments 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.

You manage and coordinate the CMC part of international development projects within parenteral nutrition
You ensure to deliver project results on time, on budget and according to the agreed Target Product Profile (TPP)
As a CMC Lead you are responsible for the design of novel parenteral nutrition products in the development phase
You work closely with the corresponding project group consisting of the various expert team members
As the CMC expert, you are accountable for the CMC deliverables, such as stability and compatibility data, product specification, manufacturing process, analytical methods and technology transfer to the manufacturing site
You are responsible for 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
You are involved in responding to authority requests
 

Your profile You have an academic background in pharmaceutical sciences, formulation science, analytical chemistry or similar education

You have at least 5 years' experience from pharmaceutical development work within the life science industry, including knowledge about the regulatory framework of CMC submissions
You gained strong experience of drug development processes
Experience in a GMP environment is a plus
Experience within project management and formulation development (e.g. emulsion expertise) or analytical method development is a merit
You have excellent communication skills and you are able to handle many internal and external contacts on different organizational levels
You are striving to build professional relationships and you are excellent in networking
You will make good use of your problem-solving skills and work in a goal-oriented manner to achieve win-win results
The tasks also imply that you have excellent planning skills, develop and convey the overall picture, monitor progress and respond to changes quickly
Good knowledge of the Swedish and English language, both orally and in writing, is a must

Fresenius Kabi in Sweden Fresenius  Kabi  Sweden with facilities in Uppsala and Brunna produce Parenteral Nutrition, IV Drugs, Additives and Raw Materials both for our own product portfolio and external customers. We have around 1100 employees. The majority is working in the production site in Uppsala (producing parenteral nutrition which is administered intravenously, for example Intralipid,Kabiven and Structokabiven, as well as supplements such as Vitalipid. We also produce anaesthesia such as Diprivan and Propofol.), that was established in 1999, while the API production Sales- (around 200 persons) is located in Brunna, Stockholm.

What you can expect
This is an exciting time to join Fresenius Kabi Sweden and an excellent opportunity for a successful and dedicated career as our new CMC Lead.
You will:
Join a global market leader with a most comprehensive product portfolio for core therapeutic areas, such as parenteral nutrition, IV drugs, additives and raw materials.
Be a member of a global healthcare group with an impressive track record of sales performance.

The position is a fixed-term employment which, after agreement between the parties, is transferred to permanent employment after 6 months.
 
If you want to know more about the position you are welcome to contact Anna Lundquist (anna.lundquist@fresenius-kabi.com).
Union representatives are Frank Glackin for Unionen, 018-644 773 and Linda Holm for Akademikerföreningen 018–644 773.
 
We look forward to your application! Selection and interviews will be ongoing during the whole application period, observe that the position may be filled before last application date, so please register your application asap. We do not accept applications by e-mail or post.

 

Do you want to join us as the global market leader with a most comprehensive product portfolio for core therapeutic areas? Don't think about it, apply now!