Spectroscopy professional for analysis and quality control in solid dosage units

• Quality
• Måløv

Do you have experience with Near-infrared (NIR) spectroscopy in a pharmaceutical setting? Do you want to make NIR a part of Quality Control (QC) in the solid dosage unit area? We are looking for a dedicated, enthusiastic and professional new colleague to develop, validate and perform NIR analysis.

You can look forward to lay the ground work for future QC NIR analysis for spectroscopy technology as well as processes, and implementing these in the QC laboratories, securing a strong collaboration between the development area and QC area.

The position spans two areas, Finished Products QC (OFP QC) and Oral Protein Formulation (OPF), with direct reference to OFP QC. The areas are a part of Novo Nordisk’s Oral area solid dosage units, with an ambition to develop world class tablet products for diabetic patients based on oral delivery of peptides.

About the department

In OFP we are approximately 400 dedicated employees in Måløv and the area is still growing. For the future we have many ambitions - together we will succeed and still strive being at the forefront of the development of technology, systems and processes etc.

Oral Finished Products Quality Control (OFP QC) employs approximately 70 highly skilled and motivated employees in five teams. The department delivers analytical support to oral protein products from clinical phase 3 to marked product. OFP QC support the production of oral finished products and ensure analytical support to manufacturing development. We are working with standardisation and optimisation of our procedures to ensure robust QC processes.

In OFP we make a huge effort for you as a new employee to be off to a good start. During the first few days you will spend some time with other new employees, where you will go through an exciting introducing plan together. The area manager will welcome you, and a colleague will act as a mentor and go through your individual training plan. We know how important it is, and we are looking forward to meeting you.

The position

The position is focused bringing NIR analysis from development to routine QC analysis in the OFP QC department.

To secure this, you will be a part of the method development group working with spectroscopy methods to analyse solids and products used in our production process of solid dosage units, from powder to tablets. Together with the group you will be pushing the spectroscopy technology usage in the solid dosage area and have an opportunity to make a positive impact with the advantages the technology offers.

You will be responsible for development and validation of NIR analysis, including study protocols, hands-on work, data evaluation and reporting.

When the methods and processes are ready for implementation in OFP QC, it will your responsibility to drive the implementation in the QC area.

The daily work will be in the group that works on real-time release testing and continuous manufacturing for future products. The focus is to implement new technology and methods and mature them to be useable in a routine setting.

Qualifications

To be a success in this role we expect that you have:

• A background as M.Sc. or PhD in Pharmacy, chemistry or related field coupled with knowledge from a GMP environment.
• Strong competencies with chemometrics and modelling of spectroscopy data, preferably with MatLab.
• Hands-on experience with NIR spectroscopy method development and validation.
• Experience with method validation.

On a personal level, you enjoy working with people from different professional backgrounds who are dedicated towards meeting our common goals. You enjoy working in a dynamic environment and are eager to see things progress. Lastly, you are good at communicating complex content to people with different backgrounds.

About Oral Finished Products in Novo Nordisk

In 2004 an ambitious and path-breaking journey began for us to become the first medical company delivering GLP-1-based tablets to the market. We have now reached that goal, which means that millions of patients with type-2 diabetes will have an oral alternative to injectable preparation. This is a result of competent, innovative and engaged employees’ efforts, who are proud to use their dedication to make totally new standards within the diabetes treatment. Join us at our journey – a possibility to make a personal and professional development.

Contact

For further information, please contact Joakim Ro-Poulsen +45 3077 6991.

Deadline

11 Dec. 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.