Drug Product Scientist
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Gentofte
Do you have a curious mindset and are you motivated by working with new processes, new products in a newly established RNAi department? Does our ambition of changing lives for patients living with chronical diseases by being at the technological forefront of the RNAi products sounds engaging? Then you are the Drug Product Scientist we are looking for!
The position
As Drug Product Scientist within formulation and aseptic production, you will participate in leading RNAi projects in close collaboration with external partners worldwide.
This will include activities such as:
You will collaborate with colleagues from development, manufacturing development, quality control, quality assurance, manufacturing facilities and regulatory affairs. As our department and the processes are new, you will be involved in defining our ways of working moving forward.
In our newly established RNAi Manufacturing Development department, we are responsible for both the product and the process regarding drug substance and drug products as well as analysis from preparation to phase 3 and submission of the regulatory file. Together with external partners we are involved in process and specification justification, quality risk assessment and control strategy.
In this position you will be travelling within Europe and the USA approximately 10-20 days a year. Therefore, you also ned to have flexible working hours to collaborate with colleagues in Europe and the USA.
Qualifications
To succeed in this role, you have:
You will be working in an international matrix organisation while collaborating with difference functions. You excel in stakeholder management, can easily collaborate cross-departmentally, have a sound personal judgement, and are used to clearly present status overviews and generate detailed plans in alignment with other areas. As a person you do well in busy environments, challenges do not scare you, and a quality mindset is at your core.
The department
Our department is part of the BRD Manufacturing Development & Quality Control area that has its base in Denmark. What other companies call Manufacturing Science & Analytical Technology (MSAT) we call Manufacturing Development. We are app. 460 colleagues who are the end-to-end station for product and process development for all BRD production facilities, driving innovation both when it comes to industry 4.0 technology and expansion of the product portfolio. Our area also includes the Quality Control unit for all BRD’s products. Together we drive change by always looking for improvements within our processes and in the way we work to make our products reach as many patients as possible.
Working at BRD, Novo Nordisk
Biotech & Rare Disease (BRD) is part of Novo Nordisk Product Supply, which is a global production network at the forefront of technology and quality production of pharmaceutical products. In BRD we are not only supplying all Novo Nordisk products for Rare Diseases, but also using our competences in Biotech to support the growing efforts into completely new production platforms and therapy areas for Novo Nordisk. We are app. 2650 colleagues committed to drive change for people with serious chronic diseases. We produce our life-saving medicines out of five state-of-the-art production sites in Denmark and United States - covering the entire production value chain where raw materials are cultivated, purified, formulated, filled, assembled in devices, packed, and distributed across the globe. Not only are we making a difference for patients – we also strive to make a difference for our employees by promoting a learning culture with high level of trust, innovation, and development for everyone. Are you ready for a life-changing career?
Contact
If you have any questions about the position or just want to get a feeling of the department and our exciting road ahead, please do not hesitate to call director, Mette Riskjær Bell at +45 30 75 76 80.
Deadline
1 January 2023. Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.
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.
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The position
As Drug Product Scientist within formulation and aseptic production, you will participate in leading RNAi projects in close collaboration with external partners worldwide.
This will include activities such as:
- Setting product specifications
- Process validation
- Trending stability
- Technology transfer
- Review of documentation
- Troubleshooting on manufacturing issues at CMOs
- Involved in authoring and reviewing of regulatory documentation
You will collaborate with colleagues from development, manufacturing development, quality control, quality assurance, manufacturing facilities and regulatory affairs. As our department and the processes are new, you will be involved in defining our ways of working moving forward.
In our newly established RNAi Manufacturing Development department, we are responsible for both the product and the process regarding drug substance and drug products as well as analysis from preparation to phase 3 and submission of the regulatory file. Together with external partners we are involved in process and specification justification, quality risk assessment and control strategy.
In this position you will be travelling within Europe and the USA approximately 10-20 days a year. Therefore, you also ned to have flexible working hours to collaborate with colleagues in Europe and the USA.
Qualifications
To succeed in this role, you have:
- An academic degree or Ph.D. within pharmacy, chemistry, engineering or a similar field
- +3 years of experience from the pharmaceutical industry within aseptic produced drug product or from development of drug product.
- Experience in outsourcing activities and in writing parts of module 3 sections of regulatory dossiers is preferred.
- Experience in managing smaller projects.
- Full professional proficiency in English.
You will be working in an international matrix organisation while collaborating with difference functions. You excel in stakeholder management, can easily collaborate cross-departmentally, have a sound personal judgement, and are used to clearly present status overviews and generate detailed plans in alignment with other areas. As a person you do well in busy environments, challenges do not scare you, and a quality mindset is at your core.
The department
Our department is part of the BRD Manufacturing Development & Quality Control area that has its base in Denmark. What other companies call Manufacturing Science & Analytical Technology (MSAT) we call Manufacturing Development. We are app. 460 colleagues who are the end-to-end station for product and process development for all BRD production facilities, driving innovation both when it comes to industry 4.0 technology and expansion of the product portfolio. Our area also includes the Quality Control unit for all BRD’s products. Together we drive change by always looking for improvements within our processes and in the way we work to make our products reach as many patients as possible.
Working at BRD, Novo Nordisk
Biotech & Rare Disease (BRD) is part of Novo Nordisk Product Supply, which is a global production network at the forefront of technology and quality production of pharmaceutical products. In BRD we are not only supplying all Novo Nordisk products for Rare Diseases, but also using our competences in Biotech to support the growing efforts into completely new production platforms and therapy areas for Novo Nordisk. We are app. 2650 colleagues committed to drive change for people with serious chronic diseases. We produce our life-saving medicines out of five state-of-the-art production sites in Denmark and United States - covering the entire production value chain where raw materials are cultivated, purified, formulated, filled, assembled in devices, packed, and distributed across the globe. Not only are we making a difference for patients – we also strive to make a difference for our employees by promoting a learning culture with high level of trust, innovation, and development for everyone. Are you ready for a life-changing career?
Contact
If you have any questions about the position or just want to get a feeling of the department and our exciting road ahead, please do not hesitate to call director, Mette Riskjær Bell at +45 30 75 76 80.
Deadline
1 January 2023. Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.
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.
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 Gentofte.
Jobbet er oprettet på vores service den 9.12.2022, 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.
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