Team Leader, PDS Manufacturing Sciences
- Ferentino, Frosinone
- Tempo indeterminato
- Full time
- Handle technology transfer activities to the manufacturing department by selecting appropriate process materials and establishing the manufacturing process.
- Support the production department to ensure flawless scheduling of manufacturing activities.
- Serve as the reference contact for our clients on process-related topics.
- Follow tech transfer projects from the kickoff meeting with the client through the entire lifecycle of the project.
- Prepare process documentation to support manufacturing activities, respecting project achievements and adhering to GMP requirements and internal SOPs.
- Provide appropriate training to production personnel responsible for manufacturing activities according to MBR instructions.
- Communicate with clients about technical aspects relevant to the project, providing updates on project activities.
- Collaborate with the Formulation Development laboratory to develop studies that define the GMP process.
- Manage the activities of a team of direct reports, more focused on commercial products.
- Degree or equivalent experience in CTF, Chemistry, Engineering with previous experience of 3 years in a pharmaceutical environment.
- Experience in the development and manufacturing process of lyophilized and liquid sterile products.
- Knowledge of filling processes in syringes and cartridges is a must.
- Capacity to coordinate the work of the rest of the team.
- GMP knowledge.
- Proficiency with main IT software.
- Leadership and independence in handling tasks.
- Strong teamwork capabilities.
- Regulation for commercial batches