Operational Lead
Operational Lead
Category: QualityLocation:Måløv, Capital Region of Denmark, DK
Are you a PAT specialist eager to drive and ensure global PAT methods are imple-mented, optimized and kept in validated state for our commercial products? As an SME at Novo Nordisk, you’ll manage lifecycle management activities for PAT & Off-line NIR methods, collaborate cross-functionally, and ensure Syn TQ orchestration meets all standards.Ready to provide technical expertise and operational guidance global sites? Join us and lead innovation in quality control!
The position
In this role, you will be responsible for operationalization of global PAT & Off-line NIR methods and Life Cycle Management activities e.g., update, re-validation, perfor-mance, and transfer across production and QC labs.
Your main responsibilities will include:
- To establish and maintain a collaboration platform with relevant stakeholders e.g., production, IT, QC, LCM and OPDev PAT
- Acting as an SME and sparring partner for the PAT team in QC L&S and across sites by providing scientific and technical expertise and guidance on e.g., GMP and regulatory requirements, and providing operational direction
- Being responsible for the Syn TQ orchestration (creation, update, and mainte-nance) for both PAT and Off-line methods and data handling
Qualifications
To succeed in this role, you:
- Hold a B.Sc., M.Sc. or Ph D in Pharmacy, chemistry, engineering, food science, or related field
- Have in-depth knowledge and experience with spectroscopy, chemometrics, data-science and applied statistics
- Have experience with PAT and Off-line NIR method LCM activities and opera-tionalization
- Have worked withing the 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 experience with regulatory guidance and industry standards e.g., (FDA, EMA, ICH, ASTM, ISPE) related to PAT and Off-line methods and procedures in GMP environment, such as knowledge of analytical instruments (including trouble-shooting, user requirements and general application).
Also, we will positively evaluate hand-on experience in the implementation and trans-fer of analytical applications to commercial production.
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, but are also able to inspire and moti-vate your colleagues by using your excellent stakeholder management skills.
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.
ContactFor further information, please contact Associate Manager Agnete Krabbe Kath at +45-30777208
Deadline17 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.