Are you familiar with upstream processes and eager to make a significant impact in our CDMO facility? If so, we have a position that might be of interest for you! We are currently seeking a new collaborator to join our manufacturing team in ThermoFisher as USP Senior Scientist.
In this role, you will play a pivotal role in the development, optimization, and scale-up of various cell culture and viral vector processes up to GMP manufacturing.
You will handle customer project for our department and own the development and implementation strategies of the projects within the operations. Your technical expertise and collaborative thinking will be essential for the preparation, production, delivery, follow-up and improvements of customer projects.
You will be responsible for all USP aspects of our customer projects, and the key point of contact for the operations (technical and scientific activities), by:
- Ensuring the robustness of the upstream development strategy for client projects.
- Designing and implementing technical studies, analyzing and communicating results through protocols, study reports, teleconferences, and customer meetings, while adhering to the principles of QbD and cGMP.
- Relaying and driving actions from customer and internal meetings to the USP team.
Coordinating and planning the technical transfer of upstream processes to GMP entities, working closely with USP Managers and Scientists/Line managers.
- Providing proficiency in drafting development protocols and reports, scale-up or process characterization, and ensuring technical and quality monitoring of clinical and commercial batches (Data, Deviations, technical CAPA).
Development of R&D activities
As the Senior Scientist, you are able to identify, propose and implement innovative solutions that bring significant benefits to the operations, by participating to manufacturing projects, in collaboration with relevant team members. You are also the referent for the USP GMP aspects and quality systems.
Giving support by:
- Being the reference in the field of investigations linked to Deviations, or technical incidents on the equipment/processes used.
- Ensuring the traceability of operations carried out within the manufacturing areas.
- Safeguarding the quality compliance by the operational team (SOPs and GMP/GLP standards).
- Promoting the 5S policy with your team in our work environment.
- Proposing improvements, or innovative alternatives.
- Motivating all the resources to improve the efficiency and productivity of the operations aiming for right first time and on-time delivery mentality.
Role complexity