Site Project Manager

vor 5 Monaten

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.

**Your Role**:
The MSAT DP within the Fill and Finish Department leads and manages all the Drug Products (DP) site technical activities within Merck Aubonne site to ensure the supply of New Biologic Entities (NBEs) part of Merck 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.

Evolving in this environment, the SPM role is:

- To lead project tasks of a molecule throughout the lifecycle of a DP manufacturing process (NPI, technology transfer, process validation, commercialization, lifecycle management etc.)
- To be CMC team member representing Aubonne Manufacturing site and to be the contact point concerning clinical and/or commercial molecule(s) in charge for internal and external relationship
- To manage projects falling under the responsibility of DP MSAT and as agreed with site management and CMC Program lead within agreed scope, time and quality such as:

- New product introductions (NPIs)
- Technology Transfer (TT)
- To Validate Drug Product (DP) processes or new product or process changes for commercial products as part of Product Life Cycle management
- Coordinate replenishment campaigns for Investigational Medicinal Products (IMPs)
- Lead optimization and/or improvements projects
- Coordinate technology transfer activities to and from Aubonne manufacturing site
- Assure the timely delivery of required documents (plans, protocols and reports, Process Control Strategy...) as defined in the project plan
- Coordinate Process Performance Qualification or Process Validation activities for large scale manufacturing.

**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

This role is a fixed contract of 6 Months.

**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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