Analytical Op&qc Lab Scientist

vor 6 Monaten

CorsiersurVevey, Schweiz Merck KGaA 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.

**An exciting new opportunity has risen at our State-Of-The-Art Biotech Development Facility in Switzerland.**

**Your role**:
Reporting to the “Analytical Operations & Quality Control Lab Manager” in the Global Analytical Development organization, Senior Scientist role represents an opportunity to work in a team of highly empowered employees and significantly contribute to the startup of high-tech GMP analytical laboratories. Once functional, this role will give you direct responsibilities in ensuring method qualification and tech transfer activities are compliant to regulatory and Merck requirements, contributing to their continuous improvement, supporting investigations and reporting, to ensure the delivery of our specialty innovator Biotech pipeline to patients. This position will also be responsible for coordinating CMC projects for QC relevant topics and supporting the team with scientific expertise in troubleshooting physico-chemical including MS and/or bioanalytical methods.

**Your key responsibilities in this role are:
- Knowledgeable on ADC CMC development with focus on analytics and robotics automation.
- Provide technical leadership and project management for CMC projects on behalf of QC team.
- Draft technical documents for the QC unit, including validation protocols and reports, risk assessments, and analytical test procedures.
- Interpret complex data and solve scientifically challenging problems by providing direction and leadership.
- Support the investigations of method performance and reliability, and proposes improvements as needed.
- Directly interact with our business partners on a regular basis, including analytical development, process and quality stakeholders and testing laboratories in the network.
- Manage, investigate and close events and deviations, non-conformities, investigations, change controls and CAPAs.
- Support preparation of audits and interact directly with internal HCQ auditors and external regulatory agencies.

**Who you are**:

- Graduate degree in Chemistry, Pharmacy, Biology, or Biotechnology. PhD is a plus.
- 7+ solid hands-on experience in method development/validation/verification and tech transfer activities within the scope of physico-chemical, electrophoretic bioanalytical (microbiological methods is a plus).
- Extensive knowledge in DoE, data analysis and statistical evaluation of qualification data sets.
- Knowledge of ADC CMC development.
- Knowledge of analytical robotic platforms in QC context is considered as a significant plus.
- Excellent investigational skills and problem-solving skills. Ability to interpret complex situations and to articulate recommendations for resolution.
- Previous direct experience in audits and interactions with healthcare authorities 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 belonging that impacts millions and empowers everyone to work their magic and champion human progress

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