IVD Manufacturing Scientist - Process & Quality Leader

Bio-Rad Laboratories, Inc; Freiburg; Hybrid; CHF 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

Competitive salary

Annual bonus & salary review

Training and development programs

Zusammenfassung

Bio-Rad in Cressier is seeking a Manufacturing Scientist (m/f/d) - 100% to join the Bio-Engineering team. You will own manufacturing processes behind our IVD blood-transfusion products, interfacing with manufacturing, quality and regulatory to keep processes robust and in control.

You will investigate non-conformities, drive CAPAs, manage change control, lead projects, and ensure documentation is audit-ready while communicating complex issues clearly to diverse audiences.

Qualifikationen

• Degree in Life Sciences (Biology/Biochemistry/Chemistry) or equivalent.
• 3-5 years in diagnostics/pharma with hands-on biology/biochemistry/ immunology and automation.
• Strong investigative mindset with root-cause analysis and risk assessment.
• Solid understanding of IVD regulatory framework (IVDR, ISO 13485, GMP).
• Structured, rigorous, with good project-management and synthesis skills.
• Fluent in French and English; German a plus.

Aufgaben

• Manage non-conformities using structured root-cause methods and define corrective actions.
• Drive CAPAs from definition to effectiveness within cross-functional teams.
• Master change control: author, review and assess regulatory impact of changes.
• Lead manufacturing projects with scope, timelines and stakeholder management.
• Own process knowledge and control strategy across lifecycle; identify variability sources.
• Author technical documents including sampling plans, SOPs, risk assessments.

Kenntnisse

Life Sciences degree

3-5 years experience

Analytical skills

Root-cause investigations

Regulatory knowledge (IVDR/ISO13485/Gx

Project management

Fluent in French and English

German a plus

Ausbildung

Degree in Life Sciences (Biology/Biochemistry/Chemistry)

Tools

Laboratory automation

Jobbeschreibung

Bio-Rad in Cressier is seeking a Manufacturing Scientist (m/f/d) - 100% to join the Bio-Engineering team. You will own manufacturing processes behind our IVD blood-transfusion products, interfacing with manufacturing, quality and regulatory to keep processes robust and in control.

You will investigate non-conformities, drive CAPAs, manage change control, lead projects, and ensure documentation is audit-ready while communicating complex issues clearly to diverse audiences.