Experienced Scientist within development and implementation of CTM Production
If you thrive by taking responsibility for meeting projects milestones and ensuring high scientific level of CMC documentation, you might be our ne
If you thrive by taking responsibility for meeting projects milestones and ensuring high scientific level of CMC documentation, you might be our new colleague in Manufacturing Development.
Bavarian Nordic is on a successful journey. We are facing an exciting development with many new vaccines in the pipeline and the establishment of a new fill and finish facility in Kvistgaard. To support our projects as well as the existing vaccine production, we are expanding the Process Development Department and are therefore looking for an experienced scientist.
In the Manufacturing Development team, we are responsible for implementation and Tech Transfer of both CTM and commercial manufacturing processes as well as the assessment of the Raw Materials used in the GMP manufacturing process.
In this position you will work closely together with colleagues from our Process Development laboratories, Production, QC laboratories, R&D, and Regulatory Affairs in projects teams where you - as scientific lead on the tech transfer packages - will help to ensure that the overall data package for the project fulfils the needs for manufacturing, release and regulatory submission of the specific products. For some of the projects, you will also collaborate with our external partners e.g. Janssen. In this position you will also take part in defining the standards of our data packages going forward.
You will work closely together with seven colleagues in the team and report to the Manager of the Manufacturing Development Team.
Ensure production readiness
- Compile and evaluate all relevant development and manufacturing data to support implementation and Tech Transfers of CTM processes
- Support Production with scientific input and review of protocols and reports for Process Performance Qualification and Process Validation
- Write protocols and reports for Technical/Engineering runs in Production
- Implement and update relevant SOPs for tech transfer activities
- Write comparability and characterization protocols and reports
- Work with statisticians for analyses of development data
Influence and responsibility
To succeed in this role you need the following qualifications:
- Master in Biochemistry, Chemical Eng., Pharmacy or similar
- More than 5 year experience from similar position within bio-manufacturing with responsibility for tech transfer, manufacturing development, manufacturing support, CMC or similar
- Previous experience from working in project groups
- Fluency in spoken and written English
As a person you like to take responsibility - also outside own area - and you show drive and influence in the project groups you work in. You are an extrovert person who thrives by sparring and collaboration with your close colleagues in the team.
We offer a very exciting position in a successful Danish, but highly international, company with a unique technology and manufacturing process within vaccine production.
You will be working in a non-formal culture, where everybody is working in the same direction. There is room for ideas and a very short way to action from the good ideas.
Caught your interest?
If you are missing some job details do not hesitate to contact Sara Post Hansen, Manager Manufacturing Development on +45 3066 3438 or by e-mail: firstname.lastname@example.org.
For more information visit http://www.bavarian-nordic.com or follow us on Twitter or LinkedIn.
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