Research Scientist, GMP Production and Quality Control
Idogen seeks a Research Scientist for our GMP production unit and quality control for clinical and non clinical activities. You will report directly to the Chief Technical Officer (CTO) and will have the opportunity to independently manage the areas of responsibility and pursue our corporate goals, and interaction with colleagues and contractors.
We are in a small biotech company located in Lund, Sweden. Idogen is founded on patented and proprietary inventions from Lund University and operated by an enthusiastic team of experts. Our focus is on developing novel cell therapy treatments for immunological diseases. The company’s frontrunner project, for the treatment of hemophilia patients with inhibitors, is currently in GMP development.
As an employee in a small biotech company the candidate will have a strong influence on the tasks performed through hard work, enthusiasm and commitment.
- Organization of the quality control, inspection of incoming goods, sampling, analysis, and reporting of results on clinical, non-clinical, and investigational medicinal products according to valid procedures
- Participate in preparation of documentation for regulatory submissions (protocols, IB, clinical study reports and IMPD)
- Monitor contractors’ compliance and reporting, and technology transfer where applicable
- Authoring and implementation of SOPs,
- Work according to appropriate GMP requirements
- Carry out validation of analytical methods and qualification of equipment
- Ensure that equipment is maintained and calibrated appropriately
- Responsible for timely (re-)validation of analytical methods and (re-) qualification of equipment
- Participate in OOS, CAPA, complaints and recall investigations
- Documentation of all work performed
- Secure maintenance and archiving of testing records and other relevant QC documentation
For this position, we envision that the successful candidate will have:
- A master’s degree or similar
- Several year’s industry experience within life science, medicine, or engineering
- Drug discovery and development industry experience with GMP
- Business level English
- Strong interpersonal relationship skills
- Strong relevant IT experience
This position involves team work inside and outside the company. We value integrity and sociability in all our team members. The successful candidate must be sociable and take decisive leadership in organizing and managing the results of our work.
Please send your application or any questions to our CTO: dennis.henriksen[at]idogen.com