Function: CMC project manager (3-5 years experience)
Role and responsibilities
You will be part of the CMC team and your role and responsibilities will be:
- Mainly to manage the clinical material supply for all clinical studies conducted by Enterome
- To participate to the management of CMC development activities (e.g DS and DP development, analytical development, manufacturing activities and stability studies for DS and DP of Enterome products).:
- To evaluate and select the appropriate CMOs in charge of the DS and DP development activities and GMP manufacturing of the clinical batches
- To manage and coordinate the activities of the CMOs, the budget and timelines with respect to quality
- To review and to approve MBR and executed BR and study protocols/reports,
- To follow and approve manufacturing deviations and investigations as needed
- To support regulatory documentation writing (i.e. IMPD, IND, answers to the authorities)
- To participate to external QA audits of CMOs as needed.
- To be part of the project team and to ensure timely completion of supply of clinical material and CMC activities for the project with several interactions with the clinical operation team
- Scientist (MSc/PhD) or pharmacist with a minimum of 3 to 5 years experience in pharmaceutical development activities with the management of CMOs in preference in biotech environment or pharmaceutical SME
- Experience with peptides or proteins-based products would be a plus
- Ability to work successfully within a collaborative team environment and as an individual contributor.
- Ability to prioritize and manage multiple complex tasks/projects within agreed timelines.
- Strong interpersonal and communication skills.
- Working proficiency (oral and writing) in English and French
- Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
- Position reporting to Chief Development Officer (CDO)