Site Project Manager

vor 2 Wochen

Aubonne, Schweiz Merck KGaA Darmstadt Germany Vollzeit

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

The MSAT DP within the Fill and Finish Department leads and manages all the Drug Products (DP) site technical activities within the Aubonne site to ensure the supply of New Biologic Entities (NBEs) part of the company's Healthcare pipeline (investigational Medicinal Products - IMPs) and the business continuity and Product-Lifecycle activities on legacy products portfolio, in compliance with specifications, registration and GMP requirements.

**Your Role**:
Evolving in this environment, Site Project Manager (SPM) will:

- Manage projects such as New product introductions (NPIs), Technology Transfer (TT), Validation of Drug Product (DP) process or new product or process changes for commercial products as part of Product Life Cycle management
- Act as main point of contact concerning clinical and/or commercial molecule(s) in charge for internal and external relationships.
- Contribute to strategy elaboration in collaboration with CMC team and other departments
- Coordinate technology transfer activities to and from Aubonne manufacturing site
- Assure the delivery of required documents (plans, protocols and reports, Process Control Strategy...) as defined in the project plan
- Establish and update the project plan to the management in collaboration with all involved parties in line with CMC project timelines and budget
- Report project progress and any discrepancy or issue related to the project plan to the management and contribute to the plan update decision in agreement with all parties
- Establish relevant change control proposals related to the projects (single or multi-site)
- Coordinate Process Performance Qualification or Process Validation activities for large scale manufacturing.
- Provide information of budgeting to CMC for DP (IMP or legacy) manufacturing
- To ensure appropriate documentation and data management using corresponding IT system, including QMS softwares (TrackWise, ManGo), ERP (SAP), Discoverant...
- Contribute to the establishment and review of regulatory files and submission files in close collaboration with RA (CMC and/or Site Regulatory Compliance) and coordinate the support from local departments
- Contribute to DP related release and shipment activities (samples or entire lot: IPC, stability, QC materials
- Ensure that due consideration is given to manufacturing requirements and potential issues as early as possible during the development of a process to be transferred and/or validated in production
- Provide training for new processes implementation, the Tech Transfer or validation strategy
- Provide molecule expertise/innovation and enrich the molecule knowledge
- Participate to internal/external audits

**Who you are**:

- Experience in R&D/Manufacturing environment (> 5 years).
- Experience in technology transfers
- Experience in leading projects
- Sound awareness of bio-pharmaceutical business, GMP related issues and Health Authorities' requirements
- Demonstrated success record in process improvements and must master and demonstrate ability to use project management tools
- Experience in a position which interacts with other departments
- Fluent in French and English

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

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