Process Development Manager
il y a 5 jours
About the Role
As a key member of the Seqens team, the Process Development Manager will play a crucial role in driving the development of processes and ensuring the technical and scientific support of the entire site. Reporting to the Operations Director, this position will oversee the activities of the development team and provide technical and scientific support to the site.
Key Responsibilities
- Define the objectives and develop the vision of the development service.
- Ensure that technical transfer leaders have the necessary skills and resources to support project teams.
- Manage knowledge of processes and products within the service and site functions.
Intendance
- Maintain the development laboratory in a state that ensures development and transfer activities; accompany and anticipate necessary evolutions in terms of methods, documentation, equipment, and premises.
- Define and implement procedures for development (e.g., SOPs, models). Ensure their creation, revision, archiving, and communication.
Validation
- Coordinate the creation and follow-up of validation plans applicable to development, transfer, and production activities.
- Ensure that validation standards exist, are maintained, and correctly applied for studies necessary in the context of development, transfers, and commercial or clinical productions.
- Participate in defining and selecting equipment and technologies, including defining user needs.
Development and Transfer
- Provide first-level technical and scientific support for any questions related to processes and products undergoing development, transfer, or clinical or commercial manufacturing.
- Work with clients to ensure a solid commercial scaling of new products.
Requirements
- Engineer or Doctor in sciences with expertise in cell therapy.
- At least 5 years of experience in a similar position in a pharmaceutical environment.
- Fluent English, project planning and management tools.
- Soft skills: proactivity, agility, relational intelligence, ability to assert oneself and make decisions.
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