PAT specialist

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Måløv

Do you have experience with spectroscopic analysis in a pharmaceutical setting? Do you want to implement PAT solutions as part of Quality Control (QC) in Oral Finished Product (OFP)?
We are looking for a dedicated, enthusiastic, and professional new colleague to develop, validate and secure continuous maintenance of different PAT solutions in Product Supply.

You can look forward to pave the way for future QC spectroscopy technologies, with solutions prepared for off-line, at-line and in-line implementation, requiring a strong collaboration between the QC area and Production area.

The position is part of OFP QC and you will initially report to New Product Entry (NPE) QC and potentially move to the Market Release QC area. Both 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 OFP QC area

In OFP QC we are approximately 140 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.

The OFP area consist of three departments:

  • “New Product Entry (NPE)” where we receive, develop and mature analytical methods for our new products
  • “Market Release” performing all the QC analyses of our marketed products
  • “Analytical Technology & Innovation” taking care of all the equipment in the area and working with innovation and new technologies

The position

As part of the NPE department the position is currently focused in bringing NIR analysis from development to routine QC analysis. 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, feedback and/or troubleshooting with production and reporting.

When the methods and processes are ready for implementation in OFP QC, it will be your responsibility to drive the implementation in the Market Release QC area, and potentially transfer to other production sites worldwide.

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 PAT methods and to mature the methods 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, food science or related field coupled with experience from a GMP environment
  • Strong competencies with chemometrics, modelling and interpretation of spectroscopy data, preferably with MatLab and/or PLS Toolbox
  • Hands-on experience with NIR spectroscopy method development and validation
  • Experience with method validation and transfer

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.

Contact

For further information, please contact Mai Stahl Madsen, Associate Manager in NPE
(email; [email protected]).

Deadline

January 19, 2023

Oral Finished Products

In 2004 Novo Nordisk initiated the ambitious and pioneering work of being the first company to offer a GLP-1 based oral alternative, to type2 diabetes patients all over the world. In 2019 we got the first approval to send our GLP-1 based tablet to the market, and we are already represented in both US, EU and other parts of the world. The pioneer spirit is what characterise Oral Finished Products. Every day we put our very best efforts in optimising and developing our production, to be able to help even more patients all over the world. And to succeed with that we need you! So get on board, our fantastic journey has just begun.

Working at Novo Nordisk

At Novo Nordisk we recognise that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and the communities we operate in.

To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

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Information og data

Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

Arbejdsstedet er beliggende i Måløv.

Jobbet er oprettet på vores service den 5.1.2023, men kan have været deaktiveret og genaktiveret igen.

Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
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