Senior Scientist Quality Control - Analytical Technology

Innovative and committed to patients worldwide.

CSL Behring is a leading global biotechnology company committed to its promise to save lives. At our site in Bern, we develop and produce life-saving therapies for people with severe and rare diseases worldwide.

For our Quality Control Technical Services (QCTS) team, we are looking for a committed individual as

Senior Scientist Quality Control - Analytical Technology (100%) (m/f/d)

In this scientific expert function, you will support our quality control laboratories with complex analytical questions and actively contribute to the optimization, validation, and transfer of analytical methods for biological medicinal products. Together with interdisciplinary teams, you will lead studies and projects, investigate complex method and performance problems, and support the introduction of new analytical technologies in a GMP-regulated environment.

Competencies and Responsibilities

• Planning, implementation, and scientific evaluation of studies and investigations to address complex analytical questions as well as ensuring GMP-compliant documentation.
• Scientific investigation of deviations, atypical results, and method performance problems, including the development of suitable testing strategies and interpretation of analytical results.
• Optimization, validation, and transfer of analytical methods for biological medicinal products as well as technical support of the methods throughout the entire analytical lifecycle.
• Supporting the quality control laboratories as a Subject Matter Expert for complex scientific and technical questions as well as for the sustainable solution of analytical challenges.
• Identification, evaluation, and introduction of new analytical methods and technologies as well as active participation in the continuous further development of our quality control.
• Creation, revision, and review of Standard Operating Procedures (SOPs), test instructions, protocols, study plans, and other GMP-relevant documentation.
• Leadership and coordination of scientific and technical projects including planning of resources, timelines, and costs for defined activities and work packages.
• Support for regulatory submissions, audits, and authority inspections as a scientific and technical expert for the respective area of responsibility.
• Close cooperation with internal specialist departments, external laboratories, and other relevant stakeholders as well as technical support, training, and coaching of colleagues within projects and analytical subject areas.

Qualifications and Professional Experience

• Completed studies in natural sciences, engineering, or a comparable technical field; a Master's or Doctoral degree is an advantage. A comparable qualification through extensive relevant industry experience is also possible.
• At least 3 years of professional experience in cGMP-regulated quality control as well as at least 2 years of experience in the development of analytical methods for biological pharmaceutical products.
• Sound experience in the optimization, validation, and transfer of analytical methods for use in a GMP-regulated environment.
• Experience in the lifecycle management of analytical methods as well as in addressing complex analytical and technical questions.
• Strong scientific and technical knowledge in an analytical field relevant to pharmaceutical quality control.
• Experience in scientific project management or in the independent management of complex project deliverables; experience in technical leadership within a matrix organization is an advantage.
• Experience in training, technical support, or coaching of colleagues is an advantage.
• Strong quality and compliance awareness as well as a sound understanding of cGMP, Data Integrity, and regulatory requirements.
• Very good German skills in speaking and writing as well as good English skills for collaboration with international stakeholders and the creation of scientific documentation.
• Analytical mindset, strong problem-solving skills as well as a structured, independent, and pragmatic way of working.
• High level of initiative, flexibility, and team orientation as well as the ability to effectively adjust priorities even with changing requirements.

About this position

• As part of our QCTS team, you will support various quality control laboratories at the Bern site and work closely with experts from different analytical subject areas.
• Your focus is on solving complex analytical challenges and the further development of analytical methods throughout their entire lifecycle - from optimization and validation to method transfer and sustainable application in the QC environment.
• The position offers you the opportunity to evaluate and introduce new analytical technologies, take on demanding scientific projects, and pass on your expertise within our QC organization.

Do you see yourself in this position? Then we welcome your CV, your work references, and your diplomas/certifications as an application.

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and co