Would you like to work within manufacturing development in a fast-growing company, which is dedicated to producing state-of-the art vaccines? Great, because we are looking for a motivated Raw Material Scientist/Expert for pre-filled syringes supporting our Raw Material strategies.
Become part of a great & high-performing team
You will become part of the Manufacturing Development (MD) Department, that is responsible for the implementation of new Raw Materials, as well as Tech Transfers, and validation of our manufacturing processes. MD is involved in a brought variety of activities for all our commercial and developmental products, including the planning and generation of CMC data to support submission to the Health Authorities, and the establishment of product & shelf-life specifications.
Currently, the department consists of 45 people and is planned to expand during the course of this year. You are going to have a close collaboration with your colleagues in the MD department, as well as with the colleagues from Production, QC laboratories, R&D, Supply Chain, Regulatory Affairs, Quality Affairs, and external partners such as GSK or Janssen, and external suppliers.
You will report to the Manager of the Raw Material team, a team composed of 9 highly skilled colleagues. The RM team has focus on the implementation and qualification of new liquid raw materials and disposables, which are employed during the manufacturing processes of both Drug Substance and Drug Product. Moreover, the RM team ensures general support for RM-related topics such as leachables/extractables, container closure integrity, and raw material stability studies.
The position
Manufacturing Development aims to expand its competencies within the field of pre-filled syringes (PFS). You can boost our team, if your profile fits to most of the following tasks and activities, required for this position:
- Experience working with aseptic production / combination devices / primary packaging for (bio)pharmaceuticals / drug delivery devices / or PFS
- Strong knowledge of PFS technology:
- Components and materials
- Filling process
- Interaction with the pharmaceutical product
- Testing
- Knowledge of Regulatory landscape:
- Familiar with high-level medical device design regulations (21CFR820, ISO 13485, MDR, ISO14971) and design control in general
- Familiar with pharmaceutical regulations, GMP and the field of CMC in general
- Experience with documentation, for instance:
- URS
- (Syringe) technical specifications
- Risk management documentation
- Experience with CMO/supplier/test house collaboration, guiding the sourcing strategy, managing vendor relationships.
- Experience with Supporting/ Designing PFS testing such as design verification, stability studies, E&L studies.
Are you our next persistent 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 due to these ambitions, we need people like you, who are determined to achieve such goals and have the following qualifications:
- 3-5 years of experience from pharmaceutical industry.
- M.Sc. (or Ph.D.) in Chemistry, Pharmacy, Chemical Engineering, Natural Science, or similar.
- Fluency in spoken and written English.
- Excellent inter-personal skills and ability to drive ambitious projects.
Who are you?
As a person you like to take responsibility also outside off your own area, by showing drive and initiative in the project groups you are working in. Moreover, you are a team player and thrive by sparring and sharing knowledge with your colleagues from the department and other related project groups. Nudging of colleagues to complete processes and documents according to timelines should be a natural part of this responsibility.
For us, it is all about improving and saving lives
Improving and saving lives through innovative vaccines is at the heart of what we do at Bavarian Nordic. We are a fully integrated vaccine company focused on the development, manufacturing and commercialization of life-saving vaccines, and our vision is to become one of the largest pure play vaccine companies in the world.
In Bavarian Nordic, we believe in the power of the team, and you will be part of a global unit with more than 1000 dedicated people representing diverse backgrounds and viewpoints. However most importantly, we are all driven and bound together by our commitment to protecting lives from devastating diseases – and we dedicate our work to this purpose every single day. We believe in creating an inclusive and flexible workplace with a strong focus on personal and professional development, because we need each other to achieve our common goals.
We operate in a world of constant flux, where we constantly explore new opportunities. So, if you are open-minded and have the willpower to succeed, we are just the perfect fit.
Could this be something for you? Ready – Set - Apply!
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!
