For our client, a leading international pharmaceutical company with headquarters in Basel, we are looking for a motivated personality in the function of:
Formulation Manufacturing Project Leader
You support drug product manufacturing process related development and supply activities for parenteral and ocular 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. You work in a cross-functional team with manufacturing operations, analytics and QA and contribute to the overall Technical Research and Development strategies and goals. You work under minimal guidance of more experienced formulation project leaders
- 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
- collaborate with operational colleagues working on your process at the respective manufacturing sites
- 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
- exchange regularly within your project team as well as seek guidance with internal experts on diverse aspects
Master degree or higher in life sciences, ideally in the Pharmaceutical field
- Ideally more than 5 years industrial experience in the development and / or clinical manufacturing of pharmaceutical formulations for small molecules and with experience in late phase development and launch activities. Experience in ocular or parenteral development preferable.
- Interdisciplinary thinking and interest in collaboration with other functions
- Good knowledge of GMP and GLP
- Good knowledge of ocular and/or parenteral dosage form technologies and laboratory and/or technical tools
- Good scientific / technical writing skills
- Good collaboration skills and team spirit enabling you to work in a matrix environment, good communication and negotiation skills
Fluent in English (oral and written), German is an advantage.
Start Date: 01.11.2021
Duration: 12 months
Please apply online. For further information about the position, please contact your Kelly recruiter, Mrs Judith Atgé Martin (+41 61 270 80 16).