Director Analytical Development Parenteral Nutrition
Fresenius Kabi AB / Kemistjobb / Uppsala
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hela Sverige 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.
The I&D 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 Director of Analytical Development will be responsible for managing a function, currently a team of 13 analytical chemists and four analytical consultants, and oversees 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 Director of Analytical Development will also be supervising the analytical work related to both product and method development as well as investigations and validations.
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. An important part of the quality work includes the implementation of FDA Title 21 CFR part 11. Future tasks will be to implement a LIMS system in the department.
As a key member of the I&D leadership team in Uppsala, the Director of Analytical Development 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 Analytical Development.
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
Independently leads and coordinates projects and investigations within I&D
Leads and coordinates development of analytical methods
Reviews and follows up on the analytical work
Drives evaluation and establishment of new analytical techniques as appropriate
Acts as Subject Matter Expert (SME) during audits and responds to authority questions
Drafts and reviews 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
Applies scientifically sound methodology and works in accordance with regulatory and quality requirements, including GMP, ISO 9001 and other internal requirements
Drives working environment issues in accordance with applicable laws and regulations and follows relevant instructions and procedures for facilities and equipment
Qualification & Requirements
This is a critical role with senior responsibilities which demands an exceptional individual with a rare combination of knowledge, skills, experience and style.
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 8+ years relevant working experience, preferably in leading multinational and virtual management teams in the medical/pharmaceutical environment
Have a thorough understanding of GMP regulated laboratory and analytical method development within pharmaceutical or medical device industry
Ideally have a knowledge about the elements of Parenteral Nutrition
Have leadership experience either from leading a function or from project management within the pharmaceutical industry
Show an inspiring leadership, characterized by developing team, facilitating change and building trust
Show good communication and interpersonal skill
Be flexible, accurate and willing to take new initiatives
Be fluent in English and Swedish, both in speaking and writing
The right candidate is driven, meticulous and analytical. He or she has proven leadership skills and the seniority needed to act as lead on multiple programs as well as the capacity to investigate, create and implement new scientific methodologies on highly critical, unique and complex projects. To be successful, it is important to have good communication skills and enjoy interacting with people on different levels within the organization. We are looking for a team player with great social skills, who appreciates to work hands on, taking responsibility for keeping deadlines and delivering high quality.
The position is initially a temporary employment with a view to become permanent employment if both parts agree after 6 months.
If you want to know more about the position you are welcome to contact Britta Siekmann, 018 644 389. 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 as soon as possible.
We do not accept applications by e-mail or post.
Varaktighet, arbetstid
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Publiceringsdatum2019-03-29Ersättning•
Så ansöker duSista dag att ansöka är 2019-04-09
Klicka på denna länk för att göra din ansökanKontaktElina Frösegård
FöretagFresenius Kabi AB
AdressFresenius Kabi AB
Rapsgatan 7
75174 Uppsala
KontorsadressRapsgatan 7
Jobbnummer 4699824
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