Stability Scientist

Innovative and committed to patients worldwide. CSL Behring is a leading global biotech company committed to its promise to save lives. At our location in Bern, with over 1'800 employees, we develop and produce life-saving therapies for people with serious and rare diseases worldwide. For our Stability Team within the quality organization, we are looking for a committed individual as Stability Scientist (m/f/d) In this scientific role, you will plan, coordinate, and evaluate stability studies throughout the entire product lifecycle, thereby making a decisive contribution to the quality, safety, and shelf life of our life-saving therapies. You will work closely with Quality Control, Manufacturing, Regulatory Affairs, and other specialist departments and take responsibility for the scientific evaluation as well as the GMP-compliant documentation of your studies. The position offers you the opportunity to continuously develop professionally and to take on additional responsibility as a Subject Matter Expert or Senior Scientist in the medium term. Competencies and responsibilities • Planning, coordination, and scientific supervision of stability studies, taking into account regulatory requirements and internal quality standards. • Creation, revision, and maintenance of study protocols, scientific reports, and other stability-relevant documentation in English. • Evaluation, interpretation, and plausibility checking of stability data as well as analysis of trends to ensure product quality. • Close cooperation with Quality Control, Manufacturing, Regulatory Affairs, Research & Development, and other internal and external stakeholders. • Support in the processing of deviations, CAPAs, changes, and risk assessments related to stability studies. • Participation in the preparation and support of internal and external audits and regulatory inspections. • Participation in the continuous optimization of processes, systems, and documentation in the area of Stability. • Support for cross-departmental projects as well as taking on own scientific tasks and sub-projects. Qualifications and professional experience • Completed scientific studies (Bachelor or Master) in pharmacy, chemistry, biology, biotechnology, or a comparable field. • Initial professional experience (ideally 2-3 years) in a GMP-regulated environment in the pharmaceutical, biotechnology, or life science industry. • Experience in the field of stability studies is an advantage, but not a requirement. • Interest in scientific data analysis; knowledge of statistics or data analytics is an advantage. • Confident use of common MS Office applications; experience with LIMS or comparable systems is an advantage. • Very good German skills in speaking and writing as well as good English skills for the creation of scientific documentation. • Independent, structured, and careful way of working as well as strong organizational and prioritization skills. • Strong communication skills, ability to work in a team, and enjoyment of collaborating with different specialist departments. • High willingness to learn and motivation to take on responsibility and to continuously develop professionally. About this position • As a Stability Scientist, you will work in a scientifically demanding and at the same time highly networked function within our quality organization. • You will coordinate stability studies, analyze scientific data, and thereby make an essential contribution to the quality and approval of our products throughout their entire lifecycle. • You can expect diverse office work with flexible working models, close cooperation with various specialist departments, and a clear development perspective toward Senior Scientist or Subject Matter Expert. Interested? Then we look forward to receiving your application with CV, work certificates, and relevant educational certificates. 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.