Senior Scientist Material Management & Qualification - Quality Control

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

Are you ready to make a meaningful impact in the world of science? Join Thermo Fisher Scientific as a Senior Scientist Material Management & Qualification within our Quality Control organization at our Lengnau site.

In this role, you will play a pivotal part in ensuring GMP compliance, material integrity, and operational excellence — directly contributing to our mission of enabling our customers to make the world healthier, cleaner, and safer.

Discover Impactful Work

As a Senior Scientist within Services & Support Quality Control, you will act as the subject matter expert for raw material qualification and release in a GMP-regulated manufacturing environment. You will ensure that materials meet regulatory requirements and remain in a continuous state of compliance.

This position requires strong technical expertise, regulatory knowledge, and the ability to lead complex quality topics across internal and external laboratories.

Key Responsibilities:

Material Qualification & Release

• In charge of raw material qualification and supporting GMP documentation, including laboratory communication
• Lead and execute material disposition activities
• Collaborate with QC laboratories to ensure compliant sampling, testing, and release of incoming raw materials.

Compliance & Regulatory Readiness

• Support OOS/OOT investigations, change control and deviation management, troubleshooting, and continuous improvement initiatives.
• Author, review, and maintain GMP-relevant documentation (SOPs, risk assessments, reports, protocols).
• Conduct gap assessments and define/implement remediation measures to maintain inspection readiness.
• SME in the area of expertise during internal audits, customer audits, and regulatory inspections.

Operational Excellence

• Drive efficiency improvements while maintaining the highest standards of compliance and product quality.
• Support implementation and optimization of digital quality systems including SAP, TrackWise, LIMS, and document management systems.
• Identify compliance risks proactively and recommend sustainable corrective and preventive actions

Who We Are Looking For:

Education

• Bachelor’s or Master’s degree in Chemistry, Biochemistry, Molecular Biology, Chemical Engineering, or a related scientific discipline.
• Equivalent professional experience in a GMP-regulated pharmaceutical or biopharmaceutical environment will be considered.

Experience

• Minimum 5 years of experience in a GMP laboratory within the pharmaceutical or biopharmaceutical industry.
• Demonstrated expertise in raw material qualification and release within a GMP-regulated manufacturing environment.
• Strong working knowledge of health authority expectations and regulatory compliance.
• Proficiency in technical English (written and spoken).

Skills & Competencies

• Strong commitment to quality, compliance, and data integrity.
• Structured, risk-based mindset with high attention to detail.
• Ability to work independently while effectively collaborating cross-functionally.
• Strong analytical thinking and problem-solving capabilities.
• Excellent communication, organizational, and prioritization skills.
• Interest in digitalization and modernization of analytical systems and QC processes.
• Continuous learning mindset with motivation to further develop technical and regulatory expertise.