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stillingsbetegnelse: Project Manager to DAPI Manufacturing Development

jobbeskrivelse:

Do you want to work with a drug substance project that ensure an effective manufacturing process for our new product? Do you want to be part of strengthen Novo Nordisk as a world leading insulin and GLP1 manufacturer? Then join the project office in Diabetes Active Pharmaceutical Ingredient development (DAPI Mdev) where we offer you the opportunity to be part of a team where high engagement, innovation and ambition are key words in solving the everyday challenges.

About the department
DAPI Project Office is a department in Diabetes API Manufacturing Development.

For both new and existing products, we execute quality improving, capacity expanding and cost saving projects. All of this by also supporting a project structure that secures continuous optimization across DAPI. We manage development projects in the phase from CMC-development to DAPI production (process challenge, establishing production facilities, production of API for clinical trials in DAPI, intermediate and API stability, TDR, TTD, validation of production facilities, transfer of analytical methods from CMC to DAPI, RA package for NDA/MAA).

The Job

As Project Manager you coordinate a portfolio of cross organisational projects with high impact on DAPI. You will manage large project and therefore also a group of specialists and project participants with different perspectives (e.g. QA, RA; QC; production and MDEV). Your main role will be to inspire and motivate the project group to deliver excellent results by ensuring clear project scopes, integrated use of risk management and project plans that ensures transparency for all project participants and key stakeholders.

For this specific project, you will be the main driver of ensuring a timely entrance for our new product at the market. This means that you will be responsible for planning and driving all relevant test (process characterisation) towards preparing and submitting applications for the authorities to assess and accept our production methods. The ultimate goal is to get to a point where the new product is in production and the related projects will change towards maintenance and optimisation.  

You will handle project related communication to stakeholders (e.g. DAPImanagement, Diabetes Finished Products (DFP), Sourcing, QA and RA) and drive process/product related questions both internally and externally, including coordinate answers to questions from authorities and address patent questions/possibilities.

You will be based in Bagsværd but will be in Kalundborg 1-2 days a week. Travel will be limited.

 

Qualifications
You hold a MSc in pharmacy, biology, engineering or similar, supplemented with a minimum of 3 years’ experience as a project manager within medical production.

You have profound scientific insight in development of manufacturing processes and are confident working in a GMP regulated environment. You have profound insight into systematic problem solving and are preferably a DMAIC, 3 Star or similar.

On a personal level, you are a self-starter who thrives with driving tasks independently. As you have a structured approach to your work, you can juggle several processes while prioritising your efforts optimally. You have a global mind-set and enjoy building relations across organisational levels and geography. Impeccable communication skills are a must as well as the ability to prepare presentation material in a high quality. Lastly, you must speak and write English at mothertongue level.

Feel free to submit your application & CV in English or Danish.

At Novo Nordisk, you will help some 366 million people who are living with diabetes. We expect high performance and the ambition to make your mark on our business. In exchange, we offer global opportunities for professional and personal development.

Contact
For further information, please call Niels Storm on +45 3075 1632.

Deadline
7th of May 2019

We will be reviewing the incoming applications on a regular basis and interviews will be held ongoing.

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C1321

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: NOVO NORDISK A/S

source: DK-STAR