Beschreibung
We are currently seeking a Senior Scientist to join an international pharmaceutical laboratory based in the canton of Neuchâtel.
Senior Scientist – Temporary Position
Main Mission
Within the MS&T External Manufacturing team, you will ensure the operational follow-up of activities carried out at external manufacturing partners (CMO). You will coordinate interactions with various technical, quality, and production contacts, while supporting technology transfer activities and commercial manufacturing operations.
Main Responsibilities
- Provide technical support for the commercial manufacturing activities of biological active substances carried out by subcontractors (CMO).
- Participate in technology transfer projects and the industrialisation of biological processes.
- Monitor the performance of production campaigns and contribute to achieving yield, quality, and timing objectives.
- Coordinate and support technical investigations, deviation management, root cause analyses, as well as the implementation of corrective and preventive actions (CAPA).
- Manage and evaluate change requests (Change Control) related to processes, equipment, or manufacturing activities.
- Identify operational, quality, compliance, or safety risks and implement appropriate action plans.
- Develop in-depth expertise of processes, equipment, and critical manufacturing parameters.
- Ensure effective communication between internal teams and external partners throughout transfer and production activities.
- Work closely with Quality, Supply Chain, Production, and Regulatory Affairs departments.
- Ensure compliance with GMP requirements, internal quality standards, and applicable regulations.
Profile Sought
- Minimum 8 years of experience in the pharmaceutical or biotechnological industry in a GMP environment.
- English B2 minimum and French B2 minimum
- Significant experience in the manufacturing of biological active substances (Drug Substance Manufacturing).
- Strong knowledge of mammalian cell culture processes (Upstream Processing - USP).
- Good mastery of therapeutic protein purification processes (Downstream Processing - DSP).
- Experience in technology transfer, production support, or MS&T activities.
- Experience in managing deviations, investigations, and technical changes.
- Excellent analytical skills and ability to solve complex problems.
- Ability to work independently and manage multiple priorities simultaneously.
- Strong focus on quality, regulatory compliance, and continuous improvement.
- Ability to collaborate and influence effectively in an international matrix environment.
- Excellent technical writing and communication skills.
- Good command of IT tools and GMP documentation.
