Principal Scientist – Analytical Development & Statistics (Drug-Device Combination Products)

jobcourier.ch; Basel; Hybrid; CHF 150,000 - 190,000; Full time

Job summary

Michael Bailey Associates sucht eine/n erfahrene/n Principal Scientist für analytische Entwicklung & Statistik in Basel. Die Rolle umfasst Methodenentwicklung, Validierung, Sampling-Strategien sowie statistische Auswertung unter Einhaltung internationaler Qualitätsstandards.

Sie arbeiten hybrid (50% Remote/50% Onsite) mit direkter Zusammenarbeit zu Regulatory Affairs, Qualität und Entwicklung, um regulatorische Anfragen fachlich zu unterstützen.

Qualifications

• Erforderlicher fortgeschrittener Abschluss in Pharmazie, Chemie, Statistik, Ingenieurwesen o.ä.
• Umfangreiche Erfahrung in analytischer Methodentwicklung/Validierung
• Fundierte Kenntnisse der ISO-Standards, Ph. Eur. und USP sowie Probenahme- und AQOL-Grundlagen

Responsibilities

• Entwicklung analytischer Methoden für Arzneimittel-Kombi-Produkte inkl. Validierung/Transfer.
• Sicherstellung der Einhaltung internationaler Regularien und Qualitätsstandards.
• Gestaltung und Optimierung von Stichprobenplänen zur Reduzierung des Probenbedarfs.
• Fachliche Leitung bei statistischen Problemen, einschließlich Normalverteilungs- und Transformationsansätzen.
• Unterstützung regulatorischer Anfragen aus statistischer/ wissenschaftlicher Sicht.
• Zusammenarbeit mit analytischer Entwicklung, Qualität und Regulatory.

Skills

Analytical reasoning

Statistical analysis

Regulatory awareness

Education

Advanced degree in Pharmaceutical Sciences/ Chemistry/ Statistics/ Engineering

Tools

Minitab

Job description

Michael Bailey Associates

Principal Scientist – Analytical Development & Statistics (Drug-Device Combination Products)

Location: Basel, Switzerland

Work Model: 50% Remote / 50% Onsite

Duration: 04.01.2027 – 31.12.2027

Workload: 100%

About The Role

We are looking for an experienced Principal Scientist with strong expertise in analytical method development, validation, and statistical analysis within the pharmaceutical and drug-device combination product environment. The successful candidate will support analytical development activities, sampling strategy optimization, statistical data evaluation, and regulatory responses while ensuring compliance with international quality standards and pharmacopoeial requirements.

Key Responsibilities

• Develop analytical methods for drug-device combination products, including method validation and transfer activities.
• Ensure compliance with international regulations, internal quality requirements, and industry standards.
• Design and optimize scientifically justified sampling plans to harmonize and reduce sample requirements.
• Act as the primary subject matter expert for statistical troubleshooting, including non-normal data distributions and data transformation methodologies.
• Lead initiatives focused on reducing unnecessary normality testing for standard project applications.
• Develop and maintain internal scientific guidelines related to sampling strategies and analytical approaches.
• Provide statistical expertise across analytical development projects within a diverse project portfolio.
• Support responses to regulatory authority inquiries from a statistical and scientific perspective.
• Collaborate closely with cross-functional teams across analytical development, quality, and regulatory functions.

Required Qualifications

• Advanced degree in Pharmaceutical Sciences, Chemistry, Statistics, Engineering, or a related scientific discipline.
• Extensive experience in analytical method development for drug-device combination products, particularly physical and mechanical testing.
• Strong expertise in analytical method validation and transfer activities.
• In-depth knowledge of ISO standards, European Pharmacopoeia (Ph. Eur.), and United States Pharmacopeia (USP), including practical interpretation and application.
• Expert knowledge of sample size determination and sampling plans based on fixed patient risk and Acceptance Quality Limits (AQLs), particularly according to ISO 3951-2.
• Advanced statistical expertise, including normality assessment, data transformation, and interpretation of complex datasets.
• Hands-on experience with statistical software such as Minitab.
• Proven ability to provide scientific justification and statistical recommendations in regulated environments.

Preferred Qualifications

• Experience working within global pharmaceutical organizations.
• Familiarity with quality and laboratory systems such as NRV and 1-QEM.
• Experience supporting regulatory submissions and health authority interactions.
• Strong stakeholder management and communication skills.

Branche: IT / Informationstechnologie

Funktion: IT / Technologie

Anstellungsart: Befristeter Vertrag