Job Description
As part of the Quality Control (QC) Project & Equipment team, you will be able to:
* To coordinate QC activities related to outsourcing technology transfer and/or routine analytical activities.
* To ensure that all QC testing related to technology transfer are performed according to established plans, good manufacturing practices, product registration files, and site quality standards.
* To ensure that documentation linked to validation is done according to defined planning to support the establishment of annual production reports for commercial and clinical molecules.
* To highlight potential project issues from a proactive manner and perform troubleshooting to avoid any project delays.
* To serve as the point of contact for Production, Manufacturing Technology Services (MTS), BioProcess Solutions (BPS), Quality Assurance (QA), and other Merck sites.
* To lead scientific expertise in analytical and validation methods at QC.
* To apply planning issued when appropriate.
* To enable efficient communication with the Technology Transfer Lead, Site Project Manager, QC Senior Specialist, QC Associate Managers, and other relevant stakeholders.
* To contribute to department and group objectives and roadmap.
* To facilitate efficient communication and strong follow-up with QC Experts to support technology transfer activities according to agreed timelines during the project.
Qualifications
* Bachelor's or Master's degree in biology, chemistry, biotechnology, or equivalent pharmaceutical experience.
* Knowledge of Good Manufacturing Practices (GMP).
* Experience in project management (PMP, PMI, IPMA) and laboratory activities.
* Knowledge in analytical methods, ideally in protein chemistry (physical and biochemistry).
* Strong communication and diplomatic skills.
* Mastery of computer tools: Office, Laboratory Information Management System (LIMS), Stableo, Minitab, etc.
* Fluency in English and French.