As part of the QC Project & Equipment team, you will be able to:
1. Coordinate QC activities related to outsourcing Technology transfer and/or routine analytical activities.
2. Ensure that all QC testing related to Tech Transfer is performed according to the established plan, good manufacturing practices, registration product files, and site quality standards.
3. Ensure that the documentation linked to the validation is done according to defined planning to support the establishment of the APR for the commercial and clinical molecule.
4. Highlight potential project issues in a proactive manner and perform troubleshooting to avoid any project delay.
5. Be the point of contact for Production, MTS, BPS, QA, and other Merck sites.
6. Lead scientific expertise in analytical and validation methods at QC.
7. Apply the planning issued when appropriate.
8. Enable efficient communication with the Technology Transfer Lead, Site Project Manager, QC Senior Specialist, QC Associate Managers, and other relevant stakeholders.
9. Contribute to the objectives and roadmap of the department and group.
10. Enable efficient communication and strong follow-up with the QC Experts to support technology transfer activities according to timelines agreed upon during the project.
Qualifications:
1. Master's or Engineering degree in biology, chemistry, biotechnology, or equivalent pharmaceutical experience.
2. Knowledge of GMP.
3. Experience in project management (PMP, PMI, IPMA) and lab activities.
4. Knowledge in analytical methods, ideally in protein chemistry (Physical & Biochemistry).
5. Strong communication and diplomatic skills.
6. Proficient in computer tools: Office, LIMS, Stabileo, Minitab, etc.
7. Fluent in French and English.
#J-18808-Ljbffr