Cobra Biologics is expanding within ATMP (Advanced Therapeutical Medicinal Products) specifically for the development and manufacturing of gene therapy products. Cobra is currently investing in new advanced facilities for large scale GMP manufacturing of plasmid DNA.
We are looking for an experienced Senior Scientist with a track record from upstream processing of biologicals including small and large scale fermentation of microbial expression systems.
You will be based in the Process Development & Support group (PD&S). The main objective of PD&S is to support manufacturing with process expertise and to prepare customer projects for manufacturing by technology transfer to Cobra. The work is carried out in highly focused cross functional teams.
Initially your main assignment will be to the project group working with the establishment of the new pDNA manufacturing process and facilities. Based on you expertise you will be responsible for implementation of the upstream manufacturing methods and processes ensuring their performance, efficiency and regulatory compliance. Examples of duties are:
Identifying process equipment and establishing user requirements specifications.
Generation process designs, process specifications and other relevant documentation
Testing, validation and commissioning of new equipment
Development of methods and work procedures
Training of operators and more junior colleagues
Contribute to and lead investigations of process deviations and change controls.
Following the establishment of the pDNA manufacturing capability you will continue to act as a subject matter expert for upstream processes, supporting manufacturing and customer projects. As Cobra is a service provider also in the fields of microbiota, protein manufacturing and aseptic fill/finish you will be involved in a variety of projects. All work is conducted according to GMP and an important part of your work is to, together with other functions within Cobra, ensure the regulatory compliance of the processes.
You will ideally have a PhD within a relevant field or an MSc combined with several years of professional experience. Experience from the microbial expression systems in bioreactors is required. Knowledge in single-use process systems and GMP manufacturing is beneficial.
You are motivated by being actively involved and working hands on in the manufacturing operations or in the lab when needed. You are self-motivated and are able to demonstrate high levels of organisational and planning skills. Applicants must be able to demonstrate strong written and verbal communication skills.
Cobra Biologics is an expanding company within an exciting field working with customers and projects globally. For the right candidate we are offering a position with many opportunities for personal development. Cobra Biologics Swedish site is located 4h north of Stockholm in Matfors, close to Sundsvall. The city and area offers a high quality of life through a rich variety of activities and the proximity to outdoor activities and striking countryside.
For further information please contact:
Ola Tuvesson, Head of Process Development & Support +46 (0)70 1093585