Director Analytical Development

Director Analytical Development to Fresenius Kabi

Hays Life Science is now recruiting a Director of Analytical Development to Fresenius Kabi in Uppsala. This is a critical role with senior responsibilities which demands an exceptional individual with a rare combination of knowledge, skills, experience and style.

The Innovation & Development Centre for Parenteral Nutrition in Uppsala develops products for a global market and the role as Director of Analytical Development is therefore of major importance. The analytical development department focuses primarily on the development of state of the art robust analytical methods for, especially, complex aqueous mixtures of amino acids, trace elements and other components relevant for parenteral nutrition development. In addition, AD plays a key role in the validation of such methods and in the transfer to QC departments in production.

The director of AD manages a team of highly skilled analytical chemistry professionals and overlooks all analytical activities within I&D. The role includes leading the team on an operational level, planning their tasks and actively participate in the team development in accordance with the I&D goals.

The position is of strategic importance and will help drive the team's execution and proactively contribute to setting up a road map to successfully tackle current and future challenges. In addition, the role includes responsibility for quality, working environment and safety procedures.

As a key member of the I&D leadership team in Uppsala, the Director of AD will drive to meet objectives efficiently and on time, in a fast-paced environment, by proving strategic direction, technical expertise, and tactical oversight for all activities within AD. The incumbent reports directly to the VP/Head of I&D Centre Parenteral Nutrition and the position is based in Uppsala.

Key responsibilities
The main tasks of the position holder include the following:

* Plan resources and competency within the function, including assigning resources to specific tasks
* Leads and coordinates development of analytical methods and review analytical work
* Communication with QC departments at production facilities with respect to method transfer
* Acts as Subject Matter Expert (SME) when it comes to analytical method development procedures, validation and transfer as well as supports responses to authority questions. Knowledge in QbD is desirable.
* Reviews and approves steering documents and procedures within the area of responsibility, e.g. qualifications and validation protocols, analytical methods, instructions and technical reports, both internal and external
* Leads evaluation and purchase of relevant equipment including qualification when applicable
* Supports or leads change control (CC) requests as required
* Supports laboratory investigations and event investigations as required
* Drives working environment issues in accordance with applicable laws and regulations and follows relevant instructions and procedures for facilities and equipment

Qualifications
The successful candidate will:

* Hold a university degree in relevant scientific discipline, such as chemistry or pharmacy. A specialization within analytical chemistry is meritorious and a PhD-degree is considered an advantage
* Have proven leadership experience within the pharmaceutical industry and show an inspiring leadership, characterized by developing team, facilitating change and building trust
* Have a thorough understanding of GMP regulated laboratory and analytical method development within pharmaceutical or medical device industry
* Show good communication skills and enjoy interacting with people of different levels within the organization
* Ideally have a knowledge about the analytical challenges presented by complex aqueous mixtures containing amino acids, including impurities and degradation products
* Is flexible and adaptable to a changeable environment
* Be fluent in English and Swedish, both in speaking and writing

About Fresenius Kabi
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.