Scientist

BÜHLMANN Laboratories AG; Schönenbuch; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Zusammenfassung

BÜHLMANN Laboratories AG is seeking a senior Scientist to lead IVD development projects, oversee cross-functional teams, and drive regulatory documentation in a GMP environment.

The role emphasizes experimental planning, data analysis, and collaboration with external experts to advance gastroenterology IVD products and ensure high-quality performance across platforms.

Qualifikationen

• Bachelor, Master or PhD in Biology, Chemistry, Biochemistry, Immunology, or related field.
• Proven experience in IVD product development, validation, and design transfer processes.
• Strong biostatistical skills and experience with data evaluation software.
• Fluent English; German is a strong asset.
• In-depth knowledge of GMP lab standards and DHF/DMR documentation.

Aufgaben

• Lead development projects across feasibility, optimization, transfer and validation phases.
• Supervise workstream contributors and coordinate cross-functional actions.
• Plan and evaluate complex laboratory experiments for IVD kit development.
• Execute immunodiagnostic assays (ELISA, PETIA, Flow Cytometry) and manage sample handling.
• Create and review DHF, DMR, SOPs, risk management files.
• Perform data evaluation and present findings to internal teams and external stakeholders.
• Initiate collaborations with external partners for product evaluations.
• Maintain instrument compliance and mentor staff in a GMP environment.

Kenntnisse

Project management

Laboratory leadership

Data analysis

Immunodiagnostic techniques

Biostatistics

Ausbildung

Bachelor/Master/PhD in Biology or related

Tools

Origin

R

ELISA

Flow cytometry

Jobbeschreibung

Scientist

BÜHLMANN Laboratories AG Vacant since : 10.09.2026 4124 Schönenbuch (BL) 100% By agreement Permanent

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?

• Work location 4124 Schönenbuch (BL)
• Workload 100%
• Employment start By agreement
• Employment duration Permanent

• By online Online form