Senior Scientist Quality Control - Biochemistry

Innovative and committed to patients worldwide. CSL Behring is a leading global biotechnology company committed to its promise to save lives. At our location in Bern, we develop and produce life-saving therapies for people with serious and rare diseases worldwide. For our Quality Control Technical Services (QCTS) team, we are looking for a committed individual as Senior Scientist Quality Control - Biochemistry (100%) (m/f/d) In this scientific expert function, you will support our quality control laboratories with complex biochemical issues and actively contribute to the introduction, validation, and optimization of analytical methods for biological medicinal products. Together with interdisciplinary teams, you will lead studies and projects and make a significant contribution to the continuous further development of our quality control in a GMP-regulated environment. Competencies and responsibilities • Planning, implementation, and scientific evaluation of studies in the field of biochemical quality control as well as ensuring GMP-compliant documentation. • Development, validation, and continuous optimization of biochemical analytical methods for biological medicinal products throughout the entire method lifecycle. • Support of the quality control laboratories with complex scientific and technical issues as well as introduction of new methods and technologies into routine operations. • Creation, revision, and review of standard operating procedures (SOPs), testing instructions, and other GMP-relevant documentation. • Leadership and coordination of scientific projects including planning of resources, schedules, and costs for defined work packages. • Support in investigations, regulatory filings, as well as representation of the biochemistry department during audits and authority inspections. • Ensuring compliance with regulatory requirements as well as the principles of GMP, Data Integrity, and quality standards. • Close cooperation with internal departments and international locations for the continuous further development of analytical methods and processes. • Active participation in cross-functional projects as well as promoting a culture of continuous improvement. Qualifications and professional experience • Completed studies (Master or PhD) in biochemistry, biology, chemistry, or a comparable scientific discipline. • Several years of professional experience (ideally 4-5 years) in the quality control of a GMP-regulated company in the pharmaceutical, biotechnology, or life science industry. • Sound knowledge of biochemical analytical procedures as well as experience in the development, validation, and optimization of analytical methods. • Ideally experience in immunology, cell culture, as well as antibody and nucleic acid analysis as well as in the lifecycle management of analytical methods. • Experience in scientific project management and in handling complex technical issues. • Strong quality and compliance awareness as well as sound knowledge of regulatory requirements in the GMP environment. • Very good German skills in speaking and writing as well as good English skills for cooperation with international stakeholders and the creation of scientific documentation. • Analytical mindset, structured and independent way of working, as well as strong problem-solving and communication skills. • High level of initiative, team orientation, and enjoyment in solving scientific issues together with various departments. About this position • As part of our QCTS team, you will support various quality control laboratories at the Bern location and work closely with experts from the fields of microbiology, biochemistry, and chemistry. • The position offers you the opportunity to continuously expand your scientific expertise and expand your portfolio long-term across various analytical specialties. Do you see yourself in this position? Then we would be pleased to receive your CV, your work references, and your diplomas/certifications as part of your 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 continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/. At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://ww