id: NDg5MDA4NiA3

reference: 4890086

documentId: 4890086

connectionPointId: 7

lastModificationDate: 1539164313013

stillingsbetegnelse:
Dynamic scientist for combined role of analytical development and CMO support

jobbeskrivelse:

Are you eager to be part of our voyage towards the break-through formulation, development and production of oral proteins? Are you an enthusiastic Analytical Scientist with motivation towards analytical development and have experience with a Contract Manufacturing Organisation (CMO) and/or with external stakeholders? Then this might be just the right career move for you.

As part of Novo Nordisk’s R&D family, Chemistry, Manufacturing and Control (CMC) Development makes a real difference for patients with chronic diseases across the world. We develop, manufacture and distribute drug candidates for non-clinical and clinical trials and represent a strong culture with a “can do” mind-set.

In our Oral Drug Product Analytical Development team, we are looking for a Scientist within analysis, chromatography and/or characterisation to contribute to the daily analytical development work in the team and to support and advise the Contract Manufacturing Organisations (CMOs) that we collaborate with. As part of CMC Development we, furthermore, have possibilities within both scientific and leadership careers, making it possible to look into leadership aspirations towards the coming future.

About the department
Oral Analytical Development is responsible for development and validation of Analytical methods  for tablet process development and batch release. We are also responsible for solid state characterisation including particle characterisation and stability studies.

In the future, we are foreseeing exceptionally interesting assignments as we are working on developing the oral products to go to market in the future. What we do is really innovative and important and in Novo Nordisk “all eyes are on us”.

Oral Analytical Development is currently 46 highly skilled and dedicated employees, Specialists, Analytical Scientists and Laboratory Technicians. Together we represent many years of scientific experience enabling us to innovate and solve exciting and challenging tasks. In future we will strengthen our collaboration with Contract Manufacture Organisation (CMO's) in order to expand our product portfolio.

The position

In this position, you combine analytical development tasks with the responsibility for CMO Support.

As Analytical Scientist, you will be responsible for analytical development and validation of analytical methods including chromatographic methods (High Pressure Liquid Chromatography (HPLC) / Ultra Performance Liquid Chromatography (UPLC) and methods for solid dose formulations (e.g. dissolution). Other key tasks may include solid state characterisation including water content and particle characterisation and support to stability, formulation and process development. Your responsibility includes planning, evaluating and troubleshooting on analytical work in collaboration with laboratory technicians and scientists and you contribute actively to ensure documentation of the analytical work and in maintaining the right quality level in the team.

 

Your responsibility for CMO support means that you will review documentation, evaluate and troubleshoot on analytical work in collaboration with the CMOs. You contribute actively to ensure that the documentation of the analytical work from the CMO lives up to current guidelines and industry standards. Further, you support the CMO in handling deviations and request changes to improve daily work processes. In this role, you will have a close collaboration with the analytical coordinator who stands for the daily coordination between Novo Nordisk as well as the CMOs and with our internal stakeholders including Oral Formulation and Process Development and Quality Assurance. For you to succeed, it is crucial that you have strong stakeholder management skills as well as an ability to understand the cultural and technical challenges linked to collaboration with CMOs.

Qualifications
You hold an MSc or PhD in Pharmacy, Engineering or a related field within analytical support. Ideally, you have gained a thorough understanding of the pharmaceutical business from a CMO or smaller pharmaceutical companies, preferably within peptide or tablet production, and have GMP experience combined with a high compliance mind-set.

On a personal level, you are a team player who also enjoys driving own area of responsibility. You are dedicated towards meeting our common goal and you are not afraid to lead the way for your colleagues and stakeholders. You are eager to see things moving forward in a dynamic environment where projects and processes vary and therefore require you to be flexible and willing to adapt. Additionally, you are a strong communicator and able to communicate complex content to people with different backgrounds and skills, motivating them to hear and follow your ideas and suggestions.

Working at Novo Nordisk
At Novo Nordisk we use our skills, dedication and ambition to help people with chronic diseases and change their lives. By working with us you will have the opportunity to do the same in a global business environment. We offer great career opportunities based on your personal skills and journey of development. We divide them into three tracks: Specialist, Project Manager or Manager.

Contact
For further information, please contact Thomas Falck Pedersen at +45 3075 7650.

Deadline
21st of October 2018.

 

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/C2310

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