Alvotech is a global biopharmaceutical company dedicated to becoming one of the leaders in the biosimilar market. Alvotech is an independent sister company of the international pharmaceuticals company Alvogen. The company is headquartered in a state of the art facility in Reykjavik, Iceland, and has an increasingly global presence and a broad network of partners around the world.
The analytical development team in Reykjavik currently comprises 16 dedicated employees working on biosimilar product method development.
Key Responsibilities and work assignments:
- Qualify and validate Cell-based Bioassays (potency assays) required for product characterization, stability and release testing of our biosimilar products.
- Preparing working cell banks.
- Microscopy work.
- Aseptic practices.
- Creation of method development protocols and reports.
- Creation qualification/validation protocols and reports.
- Creation and processing of analytical reports for biosimilarity exercises.
- Perform Cell-based Bioassays on development samples to support drug substance and drug product development.
- Analytical data collection, interpretation and ensuring proper documentation of experimental data.
- Summary and presentation of results in meetings.
The position is within the Binding and Bioassays methods group in Analytics – Pharmaceutical Sciences. The key technologies utilized by this group include: ELISA based immunoassays for residual impurities (resHCP and resProtA), Cell-based Bioassays and Binding assays (SPR, Biocore).
- Communication skills: Excellent written and verbal communication skills. Will be required to participate and make positive contribution to team meetings.
- Linguistic skills: Fluent command of the English language, both written and verbal
- Computer literacy: Proficient in use of a PC and common Microsoft packages such as Word, and Excel and the ability/interest to learn new software programs required.
- Attention to detail and precise work habits.
- Excellent skills in collecting data and accurately maintaining laboratory notebooks.
- Flexibility and the ability to work in a team-oriented environment to deliver against timelines and goals.
- Education: B.Sc/M.Sc./PhD in Biology, Biochemistry or related discipline and preferably industry experience.