Process Specialist for clinical fill & finish operations

Bavarian Nordic A/S

Fuldtidsjob
Nordsjælland

Are you experienced with filling in an aseptic production? Do you thrive on assuring that new processes are in compliance and ready for operation? Would you like to develop your academic competencies by taking responsibility for the entire finishing process: formulation, aseptic fill, visual inspection, label and pack? Then you might be the Process Specialist we are looking for!

Improving health & quality of life
At Bavarian Nordic we work to develop innovative and safe vaccines to treat and prevent cancer and infectious diseases. Our aim is to improve health and quality of life for children and adults around the world. We hope that you would like to share this mission with us.

Join a department that handles the entire value chain
Stepping into Production Support, you join a department of over 30 academics in charge of keeping our GMP facility in compliance and introducing new products. We take the product from development, scale it up to bulk production and finalize the value chain by filling it into vials on our small-scale filling line, that can fill up to 10.000 vials per batch.

We are looking for a Process Specialist for our clinical fill & finish team that currently consists of 2 dedicated employees. The team is part of Production Support and owns all processes related to finishing clinical Drug Product; formulation, aseptic filling, visual inspection and packaging. Most of our fills are for clinical trials which means that the ability to implement new products in the facility is key.

You will report to the Director of Production Support.

Opportunity to develop clinical fill & finish platform
As a part of our clinical fill & finish team you will work with process improvements to ensure that we continuously improve our ability to implement new products.

In the position as Process Specialist your key responsibilities will be:

  • Full responsibility for planning and execution of filling campaigns
  • Continuously improve our processes
  • Investigations, study protocols and reports
  • Quality Documentation: SOPs, Deviations, CAPAs, CRs
  • Risk assessments
  • Support to the ongoing production

You are the main responsible for one or more processes, so when your colleagues experience issues or need improvements on a development project in any matter related to your process step, they turn to you. You will report to the Director of Production Support.

Collaborations across the company
In the role as Process Specialist you will collaborate with colleagues across the company including Manufacturing Development, Technical Service, Operators in our manufacturing facility as well as external stakeholders such as regulatory authorities and partners during approval inspections.

Experience with fill & finish in an aseptic production
We are looking for a Process Specialist with:

  • +2 years’ experience with filling in an aseptic production
  • Experience with formulation, inspection, labelling or packaging is an advantage
  • Experience with aseptic production in a GMP environment
  • You have a master’s degree specializing in engineering, biotech, pharmaceutics or life science

As a person you work systematically and thrive on working with improvements and planning of project activities. You are used to managing your time and meet deadlines in an environment where time can be a scarce resource. You are a team player and are motivated by being a part of an ambitious and agile company. You take ownership and responsibility in your work.

We offer
A chance to become a key player in bringing new drug products to clinical trial in a very ambitious company. We offer a dynamic work environment and an opportunity to develop both your personal and academic competencies.

Caught your interest?
If you are interested in the position, we look forward to receiving your application via our recruitment system. Just click the Apply-Button on the right side of the page and you will be redirected to our application form.

Further information
If you are missing some job details do not hesitate to contact Director, Production Support, Lene Winther Schultz on Mobile no. +45 21 42 55 02.


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Bavarian Nordic A/S - hurtigt overblik


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Hejreskovvej 10A
3490 Kvistgård
Logo: Bavarian Nordic A/S
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https://jobbank.dk/job/1382737/