Manufacturing Scientist

Bio-Rad Laboratories, Inc; Freiburg; Vor Ort; 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 currently looking for a Manufacturing Scientist(m/f/d) - 100%.

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.

Your impact:

• 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.

What you bring:

• 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.

About us:

For 70 years, Bio‑Rad has been committed to innovation and transformation in the fields of science and healthcare. As one of the five largest companies in the life sciences sector, we are leaders in the development, production and marketing of a wide range of research and clinical diagnostic products. Our raison d’être is to help people live longer, healthier lives.

Bio‑Rad offers the opportunity to work with teams around the world. Here, management helps you build your career step by step, and you are encouraged to implement changes that will have a real impact.

What we offer:

Bio‑Rad's greatest asset is its people, which is why our total rewards programs offer value, quality and inclusivity while meeting the diverse needs of our ever‑changing workforce. Our robust offerings serve to enrich the wealth and well‑being of our employees throughout the various stages of an employee's work and life cycle. We are proud to offer a variety of options, including

• 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.

Non-solicitation:

Bio‑Rad does not accept agency CVs unless the agency has been authorized by a Bio‑Rad recruitment representative. Please do not submit resumes unless authorized. Bio‑Rad will not pay any fees related to unsolicited resumes.

Legal Entity: (CHE_2003)DiaMed GmbH