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 Qualification & Release (QC GMP) 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 (SME) for raw material qualification and release in a GMP-regulated manufacturing environment. You will ensure that materials and associated analytical processes 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

• Lead and execute the GMP-compliant release of raw materials used in manufacturing
• Drive the QC-related aspects of material qualification to ensure full alignment with health authority and regulatory requirements
• Serve as SME for raw material analytics, providing expert support during deviations, OOS/OOT investigations, troubleshooting, and continuous improvement initiatives
• Collaborate with internal and external laboratories to ensure robust analytical execution and data integrity

Compliance & Regulatory Readiness

• Act as investigator for deviations and assigned change controls, ensuring timely and compliant resolution
• Author, review, and maintain GMP-relevant documentation (SOPs, risk assessments, reports, protocols)
• Conduct gap assessments and define/implement remediation measures to maintain inspection readiness
• Support and actively participate in health authority and customer inspections and audits

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

About Thermo Fisher Scientific

Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell?

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Equal Opportunity

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.