Senior- Scientist

Shape the future of diagnostics – join our Development team!

BÜHLMANN Laboratories AG is an internationally active and growing life sciences company headquartered in Schönenbuch, near Basel, Switzerland. With 50 years of excellence in in-vitro diagnostics (IVD), we develop, manufacture, and distribute innovative diagnostic solutions trusted by hospitals and laboratories around the world.

To strengthen our Gastroenterology IVD Development team, we are looking for a dedicated and analytical professional as:

(Senior-) Scientist (m/w/d) 100%

In this key role, you will act as a project manager, project phase lead, and workstream leader within gastroenterology IVD product development. You are responsible for the independent, scientifically sound evaluation, laboratory execution, data analysis, and regulatory-compliant work for developing new IVD assays, optimizing existing products, validating kits, and transferring designs to Operations. Additionally, you will support unit leadership and act as a deputy for the Lead Manager where applicable.

Your Role – Strategic. Global. Impactful.

• Project Management & Phase Leadership: Lead development projects across feasibility, optimization, transfer, and validation phases; manage project plans, budgets, risk mitigation, and cross-departmental alignment.

• Workstream Management & Deputy Function: Supervise workstream contributors, coordinate multi-functional actions, and serve as deputy to the Lead Manager Gastroenterology IVD Development / Director.

• Experimental Planning & Bench Work: Plan, execute, and evaluate complex laboratory experiments for IVD kit development, assay optimization, and performance/stability assessments.

• Immunological Testing & Assays: Execute assays across multiple platforms (e.g., ELISA, PETIA, Flow Cytometry) and handle biological sample preparation (stool, blood, urine).

• Quality & Regulatory Documentation: Create and review critical technical documentation, including Design History Files (DHF), Device Master Records (DMR), SOPs, and risk management files.

• Data Evaluation & Biostatistics: Perform advanced data evaluation, apply biostatistical models, and present analytical findings to internal teams and external stakeholders.

• External Collaborations: Initiate and maintain scientific collaborations with external partners and clinical experts for product evaluations.

• Lab Management & Mentorship: Maintain instrument compliance within a GMP environment, train laboratory staff, and supervise students/interns.

Your Profile – Visionary. Collaborative. Data-driven.

• Education: Bachelor, Master of Science, or PhD degree in Biology, Chemistry, Biochemistry, Immunology, or a related field.
• Professional
  
  Experience:
  
  Proven experience in IVD product development, product validation, and design transfer processes.
• Technical & Scientific Background: Strong theoretical and practical foundation in immunodiagnostic techniques and diverse analytical platforms.
• Data & Biostatistics: Profound biostatistical skills and advanced experience with data evaluation software (e.g., Origin, R).
• Quality & Compliance: In-depth knowledge of IVD regulatory requirements, DHF/DMR creation, risk management, and GMP lab standards.
• Leadership &
  
  Soft Skills:
  
  Strong self-management, high precision, excellent collaboration and motivation skills, resilience, and assertive communication.
• Languages: Highly proficient in spoken and written English; conversational/basic German is a strong asset.

What We Offer

• A senior-level position with high visibility, project ownership, and leadership responsibility in IVD innovation.
• Close collaboration with an interdisciplinary team of experts and direct impact on international patient care.
• Dynamic, stable medium-sized business environment with modern laboratory infrastructure.

Are you ready to advance your career in gastroenterology IVD development?