R-285629 Senior Scientist Quality Control - Chemistry

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 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 - Chemistry (100%) (m/f/d) In this scientific expert role, you will support our quality control laboratories with complex chemical and analytical questions. You will lead studies and projects, develop and validate analytical methods, and actively contribute to the introduction of new technologies as well as the continuous further development of our quality control in a GMP-regulated environment. Competencies and responsibilities • Planning, execution, and scientific evaluation of studies in the field of chemical quality control as well as ensuring GMP-compliant documentation. • Development, validation, and continuous optimization of chemical and physico-chemical analytical methods for biological medicinal products. • Support of the quality control laboratories with complex scientific and technical questions as well as the introduction of new methods and technologies into routine operations. • Creation, revision, and review of standard operating procedures (SOPs), test instructions, and other GMP-relevant documentation. • Leadership and coordination of scientific projects including planning of resources, schedules, and costs for defined work packages. • Support with investigations, regulatory filings, as well as representing the chemistry 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 specialist departments and international locations for the continuous further development of analytical methods and processes. • Active participation in cross-departmental projects as well as promoting a culture of continuous improvement. Qualifications and professional experience • Completed studies (Master or PhD) in chemistry, biochemistry, or a comparable natural science 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 chemical analysis procedures as well as experience in the development, validation, and optimization of analytical methods. • Ideally experience in chromatography, spectroscopy, as well as physico-chemical analysis and in the lifecycle management of analytical methods. • Experience in scientific project management as well as in handling complex technical questions. • 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 collaboration 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 questions together with various specialist 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 in the long term across various analytical specialties. Do you see yourself in this position? Then we look forward to receiving 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 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://www.csl.com/accessibility-statement.