On behalf of our client based in Corsier-sur-Vevey, we are looking for a DSP Process Expert for a 6-month contract.
As part of the Global Drug Substance Development (GDSD) department, you will join the Manufacturing Excellence team, a group of motivated scientists and experts dedicated to cell banking, scale-up, tech transfer, and GMP manufacturing. You will be responsible for delivering the manufacturing strategy and preliminary Process Control Strategies (pPCS) at large scale for our portfolio pipeline projects (NBEs and ADCs). Your expertise will be crucial in ensuring the success of process scale-up in conformance with local and global requirements, ensuring our development strategies deliver safe and efficacious drugs to patients.
The successful candidate will play a key role as a subject matter expert and main interface within GDSD for Tech Transfer, scale-up, and large-scale manufacturing activities.
Key Responsibilities:
- Lead and organize the large-scale downstream manufacturing strategy and Technology Transfer/scale-up activities planning in accordance with the program mandate.
- Coordinate and ensure the preparation, maintenance, and compliance of protocols, procedures (e.g., pPCS, Sampling plans, Risk assessments) and reports (Dev and Manufacturing reports).
- Provide technical expertise for decision-making processes in case of issues during manufacturing activities, and ensure data collection and analysis from large-scale runs.
- Manage operational logistics, including initiating DS/mAbi material exports, raw material/process intermediate codification, and establishing Bill of Materials (BoM) in collaboration with Supply Operations.
- Drive compliance and continuous improvement by providing process expertise for raw material changes, initiating/contributing to deviations, investigations, and CAPA definition/implementation within your field of competence.
- Collaborate closely with cross-functional teams (Design, Program, Technology & Innovation, GAD, QA, Supply Operations, Regulatory Affairs) and external equipment/raw materials manufacturers.
