PAT Method Owner (Denmark, Måløv)

Jobbeskrivelse
Placering
Måløv, Denmark

Jobkategori
Quality

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Do you want to use your PAT expertise to set global standards? As a Method Owner at Novo Nordisk, you’ll ensure PAT and Off-line NIR methods meet validation require-ments and provide scientific support across global production sites. Do you thrive in troubleshoot, manage lifecycle updates, and integrate procedures with cutting-edge systems? Then apply now and join us to make a global impact!

The position
In this role, you will be method owner responsible for global methods for PAT and Off-line NIR procedures across manufacturing sites.

Your main responsibilities will include:

• Ensure PAT methods are fit for the intended use and in a validated state
• Drive and support Life Cycle Management activities e.g., update, revalidation, performance, and transfer across production sites and QC labs
• Participate/lead method troubleshooting/investigations across sites by analyz-ing data to identify anomalies and propose solutions
• Provide scientific support on PAT/process to production on a global scale
• Participate in a cross-organizational collaboration with sites (local QC, local IT, and Local Production, QA)

Finally, you will oversee and support the integration of PAT & Off-line NIR procedures with PAT management system (SynTQ), MES/electronic batch records to ensure all compliance and data monitoring needs are captured accurately.

Qualifications
To succeed in this role, you:

• Hold a B.Sc., M.Sc. or PhD in Pharmacy, chemistry, engineering, food science, or related field
• Have several years’ experience with spectroscopy techniques such as NIR, and Raman for in-line, on-line, at-line, and off-line is important
• Have experience with chemometrics and mathematical modeling
• Have worked withing he pharmaceutical, medical devices or food industry
• Are proficient in English

It will be also seen as an advantage if you have experience with SIMCA, Matlab, and Python, as well as Familiarization or experience with traditional QC method owner tasks such as CR case, deviation, OOS/OOT/OOE handling.

On a personal level, you enjoy working with people from different professional back-grounds on a global and dynamic environment. You have a can-do attitude, other than a holistic and data-driven approach and continuous improvement mindset.

Finally you are meticulous and detail-oriented.

About the department
The position is in the Launch & Scaling department in the Manufacturing Science and Technology area in Emerging Technologies. This area is part of Novo Nordisk’s oral solid dosage units, where we validate, optimize and maintain analytical methods for oral products and support QC around the world to get tablet products for patients liv-ing with obesity, diabetes, and any future oral solid dosage treatment for other dis-eases to the market.

The department currently consists of 36 employees, including professionals, laborato-ry technicians, project managers and managers, distributed in three teams.

Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.

Contact
For further information, please contact Associate Manager Agnete Krabbe Kath at +45-30777208

Deadline
17 November 2024

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. 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.