Tech Transfer Scientist
Bavarian Nordic A/S
Do you want to play a central role in ambitious projects? Are you motivated by cross-organisational tasks? Would you like to join a fast-moving international company with state-of-the-art technologies within vaccine production? Great! Then you might be our new Tech Transfer Scientist supporting strategic company goals.
Are you our next pioneer?
Succeeding with our vision of becoming one of the largest pure play vaccine companies in the world is no walk in the park, and that is why we need people who are determined to make it happen and have the following qualifications:
- Minimum 5 years of experience from similar position within pharmaceuticals.
- Appropriate scientific background, e.g. Master in Biochemistry, Biology, Chemical Eng., Pharmacy or similar.
- Fluency in spoken and written English.
As a person you take responsibility, you are organised and can work independently as well as a team player. You adapt quickly to changes with a positive, solution-oriented, curious, and can-do attitude.
Your tasks as Tech Transfer Scientist
In this position you will be responsible for the transfer of Drug Product manufacturing processes, like formulation, filling, and freeze-drying. Your tasks include:
- Author study protocols and reports that support the technology transfer
- Author or deliver input to process validation documentation
- Perform risk assessments, gap analyses, and comparability assessments
- Compile and evaluate relevant analytical and manufacturing data, in close collaboration with statisticians
- Author change requests for tech transfer projects
- Author scientific rationales
- Deliver input to and review documentation for regulatory submissions
- Ensure handover to Production and Life-Cycle Management
- Ensure continuous alignment within the department, and close collaboration with peers across the organization.
As a scientist you will work closely together with the colleagues in the Manufacturing Science & Technology department as well as colleagues across the organization, like Regulatory Affairs, Quality Control (QC) laboratories, Quality Assurance (QA), Production Development, and Commercial Production Sites including External Manufacturing sites.
Boost our team
You will become part of our Manufacturing Science & Technology Department. Besides Tech Transfer and validation of our manufacturing processes for all products, the department is responsible for planning, generation, and assessment of Chemistry, Manufacturing, and Controls data to support submission to the Health Authorities, establishment, and extension of shelf life, product specifications, as well as the assessment of the raw materials. The department currently comprises 49 people. You will join the Tech Transfer team responsible for transfers of manufacturing processes from one production site to another (or from one company to another) at all life-cycle stages, including transfer from development to commercialisation and full commercial scale transfers. The scope of projects can be both insourcing, outsourcing, and site-to-site internal transfers. We cover manufacturing processes for both Starting Materials, Drug Substances and Drug Products.
You will report to the Manager of the Tech Transfer Team in the Manufacturing Science & Technology department.
Our employees also have the advantage of being able to use our bus route, 70E, which runs from Humlebæk Station directly to our production facilities in Kvistgaard. The bus has four departures every morning and afternoon with scheduled stops at Hørsholmvej and Kvistgaard St.
The new service improves the commuting experience to and from Kvistgaard, where some of our employees can now benefit from a significant time savings of almost 40 minutes each way, making their daily commute more efficient and convenient.
Do we have your attention?
We are interviewing on an ongoing basis and look forward to receiving your application as soon as possible. We cannot wait to get to know you better!
Questions regarding the position
You are welcome to reach out to Linda Skou, Senior Manager, Tech Transfer and Validation, Manufacturing Science & Technology if you have questions regarding the position. Phone: +4561318005
Department:
Hejreskovvej 10A, Kvistgård
Lokation: Denmark
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