Analytical Op&qc Raw Material Expert

vor 2 Wochen

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.
**Analytical Operations and QC Expert in Raw Material management
The Biotech Development Center (BDC) is our Company's 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 “Analytical Operations & Quality Control Lab Manager” in the Global Analytical Development organization, this role represents an opportunity to significantly contribute to the startup of high-tech GMP facilities in the BDC, by actively leading a raw material stream for the QC. You liaise with peer QA and QC,production managers, supply chain experts and you allow the raw material management to run smoothly to ensure the delivery of our specialty innovator Biotech pipeline to patients.

**Your key responsibilities in this role are**:

- Manages the Raw Materials stream within the Quality Control Unit and ensures that all related activities are performed in accordance with the cGMPs and regulatory requirements
- Develops and/or authors raw material testing methods, procedures, and specifications in compliance with cGMPs, cGLPs and corporate requirements
- Assesses and implements compendial changes and provides Subject Matter Expertise in all applicable pharmacopeia related to raw material testing
- Reviews, evaluates and manages initiatives to improve Quality Operations overall laboratory operational efficiency and GMP performance
- Manages raw material analytical technical transfers and method validation/verification timelines
- Responsible for the control and timely disposition of raw materials used for method qualification
- Oversight of external laboratory testing and spend
- Participates in inspections/audits and may author/review raw material sections of regulatory filings as needed

**Who you are**:

- Graduate degree in Chemistry or related science
- 5+ years of experience and understanding of analytical testing methodology
- Area of specialization in Biochemistry or Chemistry
- Ability to evaluate chemical methods for comparability
- Demonstrated leadership skills
- Solid team player with advanced communication skills in English able to function within team based organization in multi-disciplinary environment including QA, Manufacturing, Supply Chain Operations
- Able to prioritize and decide appropriate course of actions. Effective at implementing decision
- Fully versed in GMP’s ICH Guidelines, FDA and other regulatory agency requirements for validation and operation of analytical functions
- Highly motivated and self-driven, and multi-task to support department and business objectives

**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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