Analytical Operations and Qc Scientist
vor 7 Monaten
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.
**An exciting new opportunity has arisen at our State-Of-The-Art Biotech Development Facility in Switzerland.**
**Analytical Operations and QC Scientist-ADI BDC team**
The Biotech Development Center (BDC) is the Merck next flagship biotech investment in line with the ambition to stay the Vibrant Science and Technology Company. The BDC is integrating analytical technologies of the future with high-tech automatized and digital laboratories, in a flexible, agile and highly collaborative environment.
**Your role**:
Reporting to the "Biochemical Methods Lab Manager" in Analytical Operation and QC Unit in the Global Analytical Development organization, this role represents an opportunity to significantly contribute to the startup of high-tech GMP analytical laboratories in the BDC, by setting status of the art technologies/approaches and operational workflow for microbiology. Once BDC is functional, this role will give you direct responsibilities in keeping operational workflow compliant to Industry guideline and deliver our specialty innovator Biotech pipeline to patients.
Your key responsibilities in this role are:
- Author, review and execute SOPs, Protocols, Reports relating to GMP microbiology processes in GMP manufacturing plant for clinical supply, related to Environmental Monitoring, microbiological test methods and related equipment maintenance
- Implement, maintain, and oversee environmental monitoring program, trending and analysis.
- Execution and/or Oversight of microbiology tests such as growth promotion, bioburden, BacT/ALERT rapid sterility, compendial sterility, and endotoxin methods.
- Conduct investigations regarding environmental monitoring (EM) action level excursions, and out of trend/specifications results for microbiological testing.
- Develop and refine strategies and methodologies for microbiological testing, cleaning validations for the assigned processes/projects.
- Perfom and oversee the day-to-day activities related to Environmental Monitoring, product release testing, and contamination control.
- Participate and support internal audits and inspection with Health Authorities by direct interactions.
**Requirements**:
- Master Degree in Biology and/or related science and 5+ years of GXP experience in the biotech and/or pharmaceutical industry specific to microbial contamination and controls. PhD is a plus.
- Proficient knowledge of regulatory guidance and industry best practices for GMP and specifically for QC microbiological field
- Expert knowledge and understanding of Microbiology principles, theories, concepts and laboratory methodologies.
- Proficient knowledge and experience in several of the following areas of competency: aseptic processing, clean room and contamination control, environmental monitoring microbiological methods and cleaning validation.
- Effective organizational skills and ability to manage multiple projects and contribute to cross-functional one.
- Demonstrated experience analyzing and interpreting technical results and summarizing these results in technical reports.
- Preferred hands-on experience with laboratory information systems, digital tools and lean principles
- Highly motivated and self-driven, and multi-task to support department and business objectives
- Comfortable and agile in change management context with mínimal direction and able to adjust workload based upon changing priorities.
- Curiosity and open minded to new tools & technology
- English fluent, French is an asset
**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
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