Site Project Manager

Vor 5 Tagen

Aubonne, Schweiz Merck KGaA Darmstadt Germany Vollzeit

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

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.

**Your Missions**:
Within the Merck-Aubonne Fill & Finish Department, the MSAT-NBEs DP team coordinates all the Drug Products activities to ensure:

- the supply of New Biologic Entities (NBEs) part of Healthcare pipeline (investigational Medicinal Products - IMPs),
- the business continuity and Product-Lifecycle activities on legacy products portfolio, in compliance with specifications, registration and GMP requirements

Evolving in this environment, and with a strong focus on NBEs and external Technology Transfers, SPM role is:

- To be CMC team member representing Aubonne site Manufacturing and to be the contact point concerning clinical and/or commercial molecule(s) in charge for internal and external relationship
- To lead and drive site activities for new product introductions-NPIs, technology transfers, validation of Drug Product (DP) process or new product or process changes for commercial products, in line with CMC requirements.
- To ensure on-time coordination of projects and production falling under the responsibility of DP MSAT-NBEs and as agreed with site management and CMC Program lead.

**Project Management**:

- Provide information of budgeting to CMC for IMP/validation batches manufacturing
- Assure the timely delivery of the technology transfer documents (plans, protocols and reports, PCS...) 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 within the local Project Review Board tool 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.
- To ensure appropriate documentation and data management using corresponding IT system, including QMS softwares (TrackWise, ManGo), ERP (SAP).
- 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 material)
- Participate to internal/external audits
- 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
- As site Molecule Expert, provide molecule expertise/innovation and enrich the molecule knowledge and its management
- Training of Aubonne site personnel

**Your Ideal Profile**:

- Education in Pharma / Biotech / Biochemistry / Chemistry or other scientific fields
- Proven technical expertise in Project Management and Tech Transfers
- Know-how on Performance Qualification or Process Validation
- Ability to interact with senior management, external customers or partners, Regulatory Affairs, Auditors etc
- Scientific acumen and sense of responsability, priority and emotional intelligence
- Fluency in French and English
- 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 molecule expertise/innovation and enrich the molecule knowledge

**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. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.

We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek ne

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