Process Expert

vor 2 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.

The MSAT & NBEs DP/Fill and Finish Department leads and manages all the Drug Products site technical activities within Merck BioPharma Aubonne site to ensure the supply of New Biologic Entities (NBEs) part of Merck 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, Process Expert role is:

- To ensure coordination of projects and production support falling under the responsibility of MSAT & NBEs DP and as agreed with site management or CMC Program lead.
- Act as a recognized Subject-Matter Expert (SME)/technical support on specific manufacturing processes such as filling technologies of aseptic products, manufacturing process engineering and validation related to aseptic or sterile Drug Products
- Knowledge of regulatory/GMP documentation and "best practices" and refer to it for driving process design/improvement
- To lead complex troubleshooting with suitable SMEs, and propose and implement improvement initiatives
- To support the development and implementation of advanced technologies such as new filling technologies (robotics) or PAT
- Develop the MSAT team in terms of scientific, technical and statistical expertise to increase process knowledge and drive improvement of process performance in terms of productivity and product quality.
- To establish, advocate and support the implementation of best practices within the manufacturing network, with a special focus on QbD, process robustness and validation of legacy products
- Contribute to SOPs, guidelines and tools to facilitate and structure manufacturing processes for aseptic products (e.g., equipment and manufacturing process qualification/validation)
- Generally, to manage projects within agreed scope, time and quality.
- To manage a team of trainees to develop capabilities to support manufacturing activities and support the development of advanced technologies, and build productive and professional relationships with industry experts, academia, and external regulators, to maintain a state-of-the-art scientific knowledge on aseptic manufacturing technologies

**EDUCATION/PROFESSIONAL EXPERIENCE**
- Master's degree in relevant fields (Chemistry, Pharmacy, Biochemistry, Bio-Engineering, Biotechology) with a minimum of 5 years of relevant industry experience.
- Good knowledge of pharmaceuticals business, of regulatory pharmaceutical guidelines (cGMP) related issues and Health Authorities requirements
- Good knowledge of F&F processes/unit operations
- Experience in international pharmaceutical companies
- Strong interpersonal skills and ability to interact positively and constructively with all functions in matrix organization environment.
- Having Good Project management skills is a plus
- Experience in protocol and report creation
- Able to handle critical situations on the shopfloor during validation activities
- Fluent in French & English.

**This is a limited contract (CDM) of 12 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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