Scientist for implementation of Process Analytical Technology (PAT)
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Kalundborg
Novo Nordisk manufacturing is growing. Join us in exciting times, where we’re ramping up our business. We are expanding to provide capacity for the production of Novo Nordisk’s current and future oral and injectable products by establishing new and ground-breaking biotech facilities in Novo Nordisk Kalundborg.
We are designing and building a new and innovative large-scale manufacturing facility for purification of innovative pharmaceutical proteins to treat patients with serious chronic diseases. The facility will be constructed at our site in Kalundborg and will be built with state-of-the-art technologies for advanced use of robotics and automation.
About the job
Would you like to be part of a newly established team that is responsible for designing, constructing and implementing robotics, modern technology and analytical equipment in a state-of-the-art purification facility. This is a unique opportunity to be part of a pioneering journey from the very early beginning. We want to deliver robust and reliable modern solutions for optimization of pharmaceutical production processes, and we are setting a high ambition for future production facilities within all of Novo Nordisk.
The position
As our PAT Lead you will be responsible for designing and implementing in-/on-line analytical systems for process monitoring, process control and process optimization (e.g. spectroscopy, gas and liquid chromatography, fluorescence etc). You will participate in planning and testing of on-/in-line analytical techniques in collaboration with colleagues from the project team and other departments as well as defining, evaluating and documenting PAT activities across the organization. The main objective is to support our protein purification production process for a wide variety of products by delivering reliable on-/in-line measurements of quality and/or product attributes in real-time.
You will work closely together with our colleagues in production, quality control, CMC, manufacturing development, and our engineering partner.
As a professional within PAT, your tasks will include
• Together with colleagues in the project team setting requirements and defining solutions for on-/in-line analytical techniques for process monitoring, optimization and control.
• Testing design solutions in our Mock-up or Technical facility built for full-scale production experiments.
• Ensuring solutions live up to GMP, GEP and other relevant regulations in the pharmaceutical industry.
• Planning and documenting validation strategies according to regulatory agencies and Novo Nordisk requirements.
The position offers great opportunities for utilizing your personal skills and experience and for personal and professional development. In return, we give you the opportunity to set your clear mark on our exciting new facility and help make a real difference for our patients.
Your workplace will be our site in Kalundborg however, we also work from Virum. It will be possible to flex between to two sites. When the facility goes into operations the main workplace will be in Kalundborg.
Qualifications
• A strong technical background within either chemical engineering, biotechnology, pharmacy, food production engineering or similar.
• Experience with on-/in-line analytical techniques such as spectroscopic (NIR, UV, IR, Raman), chromatographic (GC, LC) or other techniques.
• Experience with implementation of PAT for real-time monitoring and control of key process parameters and quality attributes.
• Knowledge of Multivariate (chemometrics) modelling skills and analytical method development.
• Knowledge of process control and optimization for pharmaceutical downstream processing.
• Experience with model building using multivariate statistical process control (MSPC) for in-line batch process monitoring evolution is an advantage but not a requirement
• Experience with setting up and executing feedback and feedforward control strategies for biologics is an advantage but not a requirement
• Preferably you are familiar with Manufacturing IT systems: MES, PCS, data historian and PAT management systems
We are looking for someone with an innovative and solution-oriented mindset. You will be working with people from various departments in the organization, both local and international, therefore you must be outgoing and ready to take the lead on finding opportunities for implementation.
About the Department
We are a new and fast-growing team working together to make our new facility a reality – and we intend to have fun while doing it. Currently, we are approx. 100 engaged and motivated colleagues. Within the coming years, we are expanding with approx. 150 new colleagues.
Contact
For further information, please contact our Project Director Thomas Busch +45 3077 5535 or Associate Manager Palle Kristensen +45 3075 0640
Deadline
December 16, 2022. We will process applications as we receive them, so please do not hesitate to apply.
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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We are designing and building a new and innovative large-scale manufacturing facility for purification of innovative pharmaceutical proteins to treat patients with serious chronic diseases. The facility will be constructed at our site in Kalundborg and will be built with state-of-the-art technologies for advanced use of robotics and automation.
About the job
Would you like to be part of a newly established team that is responsible for designing, constructing and implementing robotics, modern technology and analytical equipment in a state-of-the-art purification facility. This is a unique opportunity to be part of a pioneering journey from the very early beginning. We want to deliver robust and reliable modern solutions for optimization of pharmaceutical production processes, and we are setting a high ambition for future production facilities within all of Novo Nordisk.
The position
As our PAT Lead you will be responsible for designing and implementing in-/on-line analytical systems for process monitoring, process control and process optimization (e.g. spectroscopy, gas and liquid chromatography, fluorescence etc). You will participate in planning and testing of on-/in-line analytical techniques in collaboration with colleagues from the project team and other departments as well as defining, evaluating and documenting PAT activities across the organization. The main objective is to support our protein purification production process for a wide variety of products by delivering reliable on-/in-line measurements of quality and/or product attributes in real-time.
You will work closely together with our colleagues in production, quality control, CMC, manufacturing development, and our engineering partner.
As a professional within PAT, your tasks will include
• Together with colleagues in the project team setting requirements and defining solutions for on-/in-line analytical techniques for process monitoring, optimization and control.
• Testing design solutions in our Mock-up or Technical facility built for full-scale production experiments.
• Ensuring solutions live up to GMP, GEP and other relevant regulations in the pharmaceutical industry.
• Planning and documenting validation strategies according to regulatory agencies and Novo Nordisk requirements.
The position offers great opportunities for utilizing your personal skills and experience and for personal and professional development. In return, we give you the opportunity to set your clear mark on our exciting new facility and help make a real difference for our patients.
Your workplace will be our site in Kalundborg however, we also work from Virum. It will be possible to flex between to two sites. When the facility goes into operations the main workplace will be in Kalundborg.
Qualifications
• A strong technical background within either chemical engineering, biotechnology, pharmacy, food production engineering or similar.
• Experience with on-/in-line analytical techniques such as spectroscopic (NIR, UV, IR, Raman), chromatographic (GC, LC) or other techniques.
• Experience with implementation of PAT for real-time monitoring and control of key process parameters and quality attributes.
• Knowledge of Multivariate (chemometrics) modelling skills and analytical method development.
• Knowledge of process control and optimization for pharmaceutical downstream processing.
• Experience with model building using multivariate statistical process control (MSPC) for in-line batch process monitoring evolution is an advantage but not a requirement
• Experience with setting up and executing feedback and feedforward control strategies for biologics is an advantage but not a requirement
• Preferably you are familiar with Manufacturing IT systems: MES, PCS, data historian and PAT management systems
We are looking for someone with an innovative and solution-oriented mindset. You will be working with people from various departments in the organization, both local and international, therefore you must be outgoing and ready to take the lead on finding opportunities for implementation.
About the Department
We are a new and fast-growing team working together to make our new facility a reality – and we intend to have fun while doing it. Currently, we are approx. 100 engaged and motivated colleagues. Within the coming years, we are expanding with approx. 150 new colleagues.
Contact
For further information, please contact our Project Director Thomas Busch +45 3077 5535 or Associate Manager Palle Kristensen +45 3075 0640
Deadline
December 16, 2022. We will process applications as we receive them, so please do not hesitate to apply.
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.
Print job Send to e-mail
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Kalundborg.
Jobbet er oprettet på vores service den 27.10.2022, 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.
- Øvrige
- Kalundborg
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