Fpl Support

vor 3 Wochen


Basel, Schweiz nemensis ag Vollzeit

Job purpose to support drug product manufacturing process related development and supply activities for parenteral small molecule drug products in early 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 mínimal guidance of more experienced formulation project leaders.
- **
ID: 35532**:

- ** Employment type: Temporary via nemensis ag, 100%**:

- ** Duration: 01.09.2023 - 31.08.2024**:

- ** Salary: CHF 45. 56. / hr gross - on site position**

**Your responsibilities**:

- 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

**Your profile**:

- 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.

**Contact**:
Branche: Pharma-Industrie

Funktion: Anderes

Anstellungsart: Temporäre Arbeit