Support drug product manufacturing process related development and supply activities for oral small molecule drug products in Post POC phase. This includes the scientific evaluation and presentation of data, authoring of technical and GMP documentation, integrity checks against raw data and on-site manufacturing support to technical and clinical manufacturing campaigns.
•support drug product formulation development and manufacturing activities at internal or external manufacturing sites for assigned projects in line with the project plan, guidelines and procedures
•take accountability for formulation and manufacturing process deliverables incl. GMP related aspects and change control
•author manufacturing instructions for clinical manufacturing campaigns, compile data and interpret results, evaluate data, draw relevant conclusions and contribute to development reports and Quality risk assessment documents in close collaboration with the project teams
•perform document reviews and data integrity checks against raw data
•support deviation investigations and drive change control
Master degree or higher in life sciences, ideally in the Pharmaceutical field
Ideally up to 3 years industrial experience in the development and / or clinical manufacturing of pharmaceutical formulations for small molecules
Good knowledge of GMP and GLP Good knowledge of oral solid dosage form technologies and laboratory and/or technical tools
Fluent in English (oral and written), German is an advantage.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.