Gem job

Passionate scientist to secure transfer of new products in Biopharm Manufacturing Development

Do you want to be part of a dynamic department who among other exciting tasks holds the responsibility of bringing new products for treatment of haemophilia and growth hormone deficiencies from development to market readiness in Biopharm Aseptic Production? Then this position will suit you.

The department
In Biopharm Finished Product Manufacturing Development in Gentofte we are approximately 60 engaged and open-minded colleagues organised in 4 teams.

We are responsible for
• transfer of new products from development to our production facilities in Product Supply (PS)
• the product and process specifications of Biopharm’s drug products
• writing the associated documents to authorities worldwide
• ongoing optimizations of our many processes
• support to our aseptic production departments

Furthermore, we have a strong focus on innovation and optimization of the processes in Biopharm’s factories and utilise our test laboratory to further increase focus on science and implementation of new technology.


The position
As a professional within our liquid products and transfer team your responsibility is to secure transfer of new products from the development area, CMC (Chemistry, Manufacturing and Control), to commercial manufacturing sites in Product Supply (PS) and make the process and product ready for the market.

Your role is to take responsibility of the entire drug product (DP) manufacturing process and ensure that it results in a quality product, meeting all its predetermined specifications. To do this, you will be involved in many different disciplines, including risk assessments, control strategies, characterisation studies and planning, execution and documentation of test and process validation batches. Also, a major task is to coordinate, facilitate and document manufacture of materials for clinical phase 3 trials.

To succeed with all this, you will need to combine your practical experience and process understanding with the chemical properties of the product. You will also have to be present in the manufacturing facilities at a regular basis to gain hands-on knowledge and build relations in the different departments.

You will support the production departments with your expertise and knowledge, whenever they need it, and thereby secure transfer of not only products and processes but also knowhow. You will be the person driving collaboration processes in an ever-changing environment with many different stakeholders and production-related concerns. When necessary you will be driving root cause analysis and trouble-shooting sessions in cooperation with the production departments.


Qualifications
• You hold a master’s degree in science within Pharmacy, Chemistry, Engineering or a similar field
• You have experience from +4 years within the field of CMC or manufacture, e.g. process or product support, transfer or process validation.
• Experience within formulation, sterile filtration, filling and/or inspection of aseptic products will be an advantage
• You see new possible investigation avenues when test results deviate from expected outcome

As a person you are curious and work well with many different employee groups. You never compromise on quality and at the same time you are good at completing your tasks in time and move on to new tasks with energy and enthusiasm. You are a team player – openminded, engaged and able to inspire and motivate your colleagues. 

You possess good communication skills in both oral and written English and preferably also Danish.


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