Experienced Professional passionate to support Biopharm new products portfolios/marketed product
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Gentofte
- Manufacturing
- Gentofte
Are you passionate about bringing products for treatment of haemophilia and growth hormone deficiency from development to market readiness? Are you experienced with pharmaceutical manufacturing processes, defining regulatory strategies, project coordination and timely documentation? Then this job may be a great opportunity for you to create a life-changing career with us.
About the department
You will be a part of the Biopharm Finished Product Manufacturing Development, Biopharm, Novo Nordisk. The department is located in Gentofte and we are approximately 65 engaged and open-minded colleagues organised in 4 teams.
The department is responsible for the specifications of Biopharm’s liquid and lyophilised drug products, for transfer of products from Chemistry, Manufacturing and Control (CMC) to general production in Product Supply (PS) and between facilities and to support for our production departments, ongoing optimizations of our many processes. Furthermore, we have a strong focus on innovation and optimization of the processes in Biopharm’s factories, which ensure efficient production of products for patients worldwide. We will in near future build a test laboratory, so science and implementation of new technology are in focus.
The job
Your responsibility will be to create new documentation for our portfolio of products to ensure the required product quality is fulfilled and thereby, securing patient safety. You will write and review documentation defining specifications, shelf-life stability studies, risk assessments, as well as regulatory submission documents to health authorities. All of this is conducted in cooperation with colleagues in our stability team, quality control (QC), quality assurance (QA), production, and regulatory affairs (RA).
Other tasks will be to define regulatory story line for submissions of new products or line extensions, to define the necessary process validation and stability set-up documenting optimised processes in the Aseptic Production ex. using ICH Q12 guideline.
You will be driving root cause analysis and trouble-shooting sessions. You will also be identifying, developing and executing optimisations of daily routines and general processes, and support the production with your expertise and knowledge, whenever they need it. You will be the person driving collaboration processes in an ever-changing environment with many different stakeholders and production-related concerns.
Qualifications
You are an experienced engineer, chemist or similar. You have a minimum of four years of experience from the pharmaceutical industry, and hence, you are used to work in accordance with GMP.
It is considered an advantage, if you have experience within the regulatory field. Knowledge with stability, aseptic production, compatibility, process validation and/or pharmacopeia requirements is preferable. You are professionally proficient in both written and spoken Danish and English.
As a person, you are responsible, dedicated and have open-minded approach and a solid quality mind-set. You have a positive approach to your job and thrive in a changing environment and with unexpected situations. You will work together with many different people, and therefore, it is important that you are able to motivate your colleagues and to at establishing good relationships.
Working at Novo Nordisk
At Novo Nordisk, your skills, dedication, and ambitions help us change lives for the better. In exchange, we offer unique possibilities for professional and scientific development in an informal working environment, and the chance to integrate into a dynamic team of highly qualified and enthusiastic colleagues.
We will interview candidates continually, as we receive the applications.
Contact
If you want to know more about the position, please contact Anne-Mette Haahr +45 3079 8863
Deadline
4th December 2020
#LI-AMS
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 25.11.2020, 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
- Gentofte
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Statistik over udbudte øvrige i Gentofte over tid
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