Process Specialist formulation
Bavarian Nordic is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of cancer immunotherapies and vaccines for infectious diseases. The company has a diverse and growing portfolio of vaccines, supported by proprietary development, public-private partnerships and industry collaborations. The company was founded in 1994 and has been listed on the Nasdaq Copenhagen Stock Exchange since 1998. Headquartered in Kvistgaard, Denmark and with operations in Munich, Germany and North Carolina, USA, the company employs more than 400 people. Bavarian Nordic is an Equal Opportunity Employer. For more information visit http://www.bavarian-nordic.com or follow them on Twitter or LinkedIn.
Bavarian Nordic is now building a new factory for Fill and Finish. In the new factory a formulation and thawing area is designed. The formulation is handled in single use closed process equipment. The factory will run as a real multi product filling line.
Bavarian Nordic is looking for a Process Specialist to handle the professional responsibility for the formulation and thawing processes in the new factory. During the project period, you will be an important part of the team, ensuring that the formulation and thawing processes will be a success with right timelines. You will work in close cooperation with the Work Package Owner and the Equipment Specialist, both working with formulation and thawing processes.
Process Specialist formulation
Take part in creating tomorrow’s vaccines
- Leading company within its field of activities
- Highly qualified colleagues with a lot of team spirit
- You have a positive attitude, are committed and strive for results
Your responsibility as lead Process Specialist will be to support implementation of the new formulation and thawing processes in the new factory. You will secure, that the process is completely ready for PQ/PPQ. After PPQ you will continue working as a Process Specialist ensuring that the formulation and thawing processes always is operational and in compliance and fore fill the ramp-up plan to meet the demands from the market.
It is also the responsibility of the Process Specialist to ensure full descriptions of correct handling, risk assessments, ensure right trending, fully describe all CPP's in the process to keep it in control, generate and keep updating process description in SOP, ensure smoke study and aseptic process simulation where needed, secure the right training of the staff working in the process and ensure initial - and re-validation program. During all these tasks, you will work in close cooperation with other specialist in Bavarian Nordic.
When your colleague’s experience issues or need improvement on a development project in any matter related to your process step, they look to you and in all your endeavours, you collaborate with your colleagues.
You validate research together with Process Development and when you implement new equipment or optimise what we have got, Technical Service will assist you. Furthermore, QC continuously analyse samples from our production and Environmental Monitoring test our aseptic environment. Also, you will collaborate with external stakeholders such as authorities on regulatory approvals.
Some travel time in the project period must be expected, as you will be participating in vendor meetings.
Bavarian Nordic offer you a challenging position within a dedicated company, characterized by high quality, result orientation and speedy realization of the goals. Since Bavarian Nordic experience rapid growth, there will be good career opportunities. You will refer to the Director, Finished Goods.
You hold a Master’s degree and some years of experience within Pharma, where you have worked with GMP production. You hold thorough knowledge of formulation and thawing processes and have been working with validation of formulation and thawing processes. Knowledge of 4P operational training, TWI methods or other training systems would be an asset. You are used to IT and will be trained in Bavarian Nordics systems. You are of course fluent in Danish and English both spoken and written.
As a person, you have a positive attitude, are committed and strive for results. It is important that you are focused, can prioritize and keep calm when deadlines are tight. You are good at solving problems and thrive with a heavy workload. You like to deliver quality and be on time in the process. You manage to drive the project in a good manner and at the same time motivate people around you to do their best. In other words, you have a desire to support and enrich Bavarian Nordics’ culture and would love to work in a leading company producing vaccines.
Best Talent is responsible for your employment at Bavarian Nordic and review your application on a confidential basis. Forward your application including your CV in English marked ”1620/Formulation” by e-mail to firstname.lastname@example.org. Read more about Best Talent on www.besttalent.dk.