Senior Scientist – Drug Product Development (Process Development)

We are looking for experienced and motivated Process Development scientist to join the Drug Product Development team at Alvotech, Reykjavik. In this position, you will be a part of a team working on the development of liquid/lyophilized biologics (biosimilar) drug products.

Scope and responsibility

• Perform activities related to the development of robust liquid/lyophilized drug product manufacturing processes, selection of process material vendors, and process characterization to ensure that a sufficiently robust drug product manufacturing process has been developed to support process performance qualification.

• Design, perform and report process development studies, stability studies, biophysical characterization and other studies leading to the development of robust manufacturing processes according to Quality by Design (QbD) principles and internal policies. This includes, but is not limited to: freezing/thawing-, mixing-, filtration-, filling-, lyophilization processes and other drug product manufacturing related process steps.

• Participating in technical transfer from drug product process development to drug product manufacturing. Support process performance qualification as required.

Job requirements

We are looking for flexible, open-minded and motivated scientists that are excited about biopharmaceutical development, can challenge their work by innovative and creative solutions, and share our values of team spirit and team efforts. The specific requirements are detailed below.

• MSc/PhD in biotechnology, chemical engineering, biomedical engineering, pharmaceutical science, biochemistry or other related disciplines.

• 5+ years’ experience in biopharmaceutical development, including comprehensive knowledge of drug product manufacturing processes (including lyophilization), protein stability and general biologics drug product development.

• Hands-on experience in working with proteins in a biochemical laboratory.

• Proactive team player with strong communication, organization and presentation skills.

About the Department

The Drug Product Development team consists of dedicated scientists, whose goals and commitments are to develop drug product formulations, manufacturing processes and dosage form materials for biosimilar drugs. We offer an exciting and challenging working environment with a unique opportunity for personal- and scientific growth for both experienced and recently graduated scientists.