Bio‑Rad in Cressier is currently looking for a Manufacturing Scientist (m/f/d) - 100%.
Role Overview
As an MSAT Scientist within our Bio‑Engineering team, you are a technical owner of the manufacturing processes behind our IVD blood‑transfusion products. Working at the interface between manufacturing, quality and regulatory (IVDR, ISO 13485, GMP), your mission is to keep our processes robust, compliant and under control – investigating non‑conformities, driving CAPAs, leading projects, and assessing the regulatory impact of changes.
Responsibilities
- Manage non‑conformities (NC): lead technical investigations using structured root‑cause methodologies (Ishikawa, 5‑Why, FMEA) and define effective corrective and containment actions.
- Drive CAPAs: own corrective and preventive actions from definition to effectiveness check within cross‑functional teams.
- Master change control (CC): author, review and approve change requests, and assess their process, validation and regulatory impact.
- Lead manufacturing projects: manage scope, timelines, risk and stakeholders from initiation to close.
- Own process knowledge: maintain deep understanding of the processes and their control strategy across the product lifecycle, identifying key sources of variability and root causes of failures.
- Author technical documentation: sampling plans, SOPs, risk assessments, protocols and technical reports – clear and audit‑ready.
- Communicate effectively: summarise complex technical and quality issues for diverse audiences to support sound decision‑making.
Qualifications and Skills
- Degree in Life Sciences — Biology, Biochemistry, Chemistry or equivalent (Dipl. Ing., M.Sc.).
- Minimum 3‑5 years of experience in the diagnostics or pharmaceutical industry, with hands‑on knowledge of biology, biochemistry and/or immunology techniques and automation. Knowledge in immune‑hematology a plus.
- Strong scientific background and analytical capabilities, with robust investigation methodologies (root‑cause analysis, risk assessment).
- Technical and laboratory skills for investigation: hands‑on bench work is part of the role to characterise issues, run tests and verify hypotheses.
- Solid understanding of the IVD regulatory framework (IVDR, ISO 13485, GMP) and the ability to assess the regulatory impact of changes.
- Structured, methodical and rigorous, with strong project‑management and synthesis/communication skills.
- Fluent in French and English, German a plus.
Benefits
- A competitive salary.
- Annual bonus and salary review.
- Training and development programs, with access to LinkedIn Learning.
Equal Opportunities
Bio‑Rad is committed to preventing discrimination and promoting equal opportunities. All our positions are open to people with disabilities. Don’t hesitate to apply!
#J-18808-LjbffrManufacturing Scientist Arbeitgeber: Bio-Rad Laboratories
Bio-Rad Laboratories in Freiburg ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern nicht nur ein wettbewerbsfähiges Gehalt und jährliche Boni bietet, sondern auch umfangreiche Schulungsprogramme zur Förderung der beruflichen Entwicklung. Die Unternehmenskultur fördert Teamarbeit und Innovation, was es den Mitarbeitern ermöglicht, in einem dynamischen Umfeld zu wachsen und ihre Fähigkeiten kontinuierlich zu erweitern. Zudem profitieren die Mitarbeiter von der Lage in Freiburg, einer Stadt mit hoher Lebensqualität und zahlreichen Freizeitmöglichkeiten.
