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lastModificationDate: 1562761840570

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

jobbeskrivelse:

Are you eager to be part of our voyage towards the break-through formulation, development and production of novel pharmaceutical peptides and proteins? Are you passionate about analytical development? Do you have a background within analysis and characterisation and experience working with a contract manufacturing organisation (CMO)? Then this might be just the right career move for you.

About the department

As part of Novo Nordisk’s R&D family, Chemistry, Manufacturing and Control (CMC) Development develops, manufactures and distribute drug candidates for non-clinical and clinical trials.
 

The department, CMC Analytical Support, is organised into four highly skilled analytical teams with a total of 71 employees. The department is responsible for developing analytical methods, validation, documentation and delivering analytical results for new drug substance, drug product and side chains as well as for raw materials, excipients and various process related residues and leachables. Furthermore, we are responsible for solid state characterisation including particle characterisation and stability studies. 

Providing analytical support to all parts of Novo Nordisk, the department acts as a link between the research unit and the production, spanning from early development to phase 3 clinical trials and registration. Together we represent many years of scientific experience enabling us to innovate and solve exciting and challenging tasks. In future we will further strengthen our collaboration with CMO's in order to expand our product portfolio.
 

The position

In this position you will be a part of our Raw Materials, Side Chains and Residues team, where your main responsibility will be oriented towards supporting the CMOS that we collaborate while also contributing to the daily analytical development work in the team: 

Your responsibility for CMO support means that you:

• review documentation, evaluate and troubleshoot on analytical work in collaboration with the CMOs.
• support the CMO in handling deviations and request changes to improve daily work processes.
• have a close collaboration with the analytical coordinator who is responsible 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.

 

You will also contribute to tasks related to:

• analytical development and validation of analytical methods including chromatographic methods, e.g. High Pressure Liquid Chromatography (HPLC) / Ultra Performance Liquid Chromatography (UPLC) as well as other analytical techniques used for identification and quantification of small molecules and peptides.
• planning, evaluating and troubleshooting on analytical work in collaboration with laboratory technicians and scientists

 

Both parts of the job include ensuring that the documentation of the analytical work from the CMO lives up to current guidelines and industry standards. 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 have a Master’s degree within Life Sciences (Pharmacy, Engineering or other relevant discipline) and/or a PhD combined with:

• GMP experience and a high compliance mindset
• a thorough understanding of the pharmaceutical business from a CMO or smaller pharmaceutical companies, preferably within peptide or tablet production
• practical experience within HPLC/UPLC and LC-MS analytical development
• good knowledge of general protein chemistry and a natural flair for thinking in new solutions and automation.
   

It is an advantage, if you also have

• knowledge of additional techniques such as GC/GC-MS or ion chromatography
• programming and mathematic modelling skills
• master both English and a Scandinavian language (Swedish, Danish or Norwegian).

 

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 enjoy working in a dynamic environment where projects and processes vary and therefore require you to be flexible and willing to adapt. Additionally, you are able to communicate complex content to people with different backgrounds and skills, motivating them to hear and follow your ideas and suggestions.

Contact
For further information, please contact Gry Ravn Jespersen at +45 3079 6452.

Deadline
15^th of August 2019.

 

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