Project Manager (M/F)
The position will report to the General Manager, as a Project Manager to lead the transfer of Molecular Diagnostics Assay and Sample Prep manufacturing. The successful candidate will be responsible for all project deliverables, from project planning to completed design transfer and process validation.
- Establish and maintain project timelines and secure resources for transfer
- Ensure knowledge transfer and cross-site training of personnel
- Prepare the building, ensure permits are in place, and oversee equipment and material transfer
- Collaborate with key stakeholders in supply chain and across sites to manage inventory, and production ramp-up
- Establish regular reporting to all levels of the business, and coordination with other businesses; establish multiple channels of communication with all stakeholders across sites, regions, and business areas.
- Ensure the successful completion of equipment qualifications, process validations and design transfer of all assays and reagents
- Identify and oversee the implementation of any changes to IT systems required to support manufacturing
- Coordinate on-going workflow, project plans and output; serves as the single point of escalation for the transfer of manufacturing
- Maintain processes to ensure project management documentation, status reports and plans are relevant, accurate and complete.
- Maintain business continuity throughout the transfer.
- BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience.
Knowledge and Experience:
- Typically 3+ years of successful experience in operations or project management in the IVD or similar industry
- Ability to manage complex projects in high sensitivity environments
- Prior manufacturing or quality experience in molecular diagnostics
- Knowledge of quality requirements (FDA CFR 820, ISO 13485, IVDD)
- Prior experience in change control and change management
- Demonstrates comprehensive knowledge of organization's business practices and how to resolve complex issues quickly
- Direct management experience preferred
- Cross-cultural adaptability and sensitivity
- Advanced degree MAY be substituted for experience, where applicable.
Key Working Relationships:
The successful candidate will be expected to work across a broad number of functions, regions and internal/external contacts.
The position will be based in Luxembourg.
If you feel that our job profile matches your qualifications and personality, please do not hesitate and send us your application in English, including CV, covering letter and your expected salary, by post or email to the following address:
Fast Track Diagnostics S.à.r.l.
Ms. Elisabeth CHACTOURA
29, rue Henri Koch- L-4354/ Esch s/ Alzette