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Über
Position Purpose
• Design, planning, execution, documentation and reporting of laboratory experiments and investigations related to process improvements, process changes, alternative raw materials, and deviations on manufacturing process and/or on licensed products, with a focus on fractionation process and albumin.
• Apply state-of-the-art process development tool and methodologies, DoE methodologies, perform statistical data analysis.
• Support compilation of technical documents for regulatory activities.
• Onboarding, training, and guidance of laboratory staff within assigned projects.
• Contribute as SME to projects / task forces and present study / investigation results.
• Collaborate with other CSL internal departments, and external institutes and universities.
• Drive continuous improvement, innovation and modernization of the Lab equipment, working procedure, methodologies.
Main Responsibilities and Accountabilities
• Scientific and technical leadership of assigned projects in close coordination with the line manager.
• Design, planning, execution, documentation and reporting of laboratory experiments and investigations related to process improvements, process changes, alternative raw materials, and deviations on manufacturing process and/or on licensed products, with a focus on HAB, AlbuRx and fractionation.
• Contribute as SME to global RD projects / task forces and present study / investigation results.
• Onboarding, training, and guidance of laboratory staff within assigned projects.
• Regular reporting of project status to the line manager.
• Writing, reviewing and revision of SOPs.
• Archive all relevant documentation according to applicable guidelines.
• Contribute to equipment calibration and qualification according to applicable quality standards.
• Collaborate with other CSL internal departments, and external institutes and universities.
• Drive continuous improvement, innovation and modernization of Lab equipment, working procedures and methodologies.
• Comply with all safety guidelines and regulations, use safety equipment correctly, and attend safety training.
• Wear protective equipment consistently and replace when defective where prescribed and required.
• Eliminate hazards and risks immediately where possible, otherwise report them to the supervisor immediately.
• Contribute to the achievement of safety goals and actively contribute to improvements in safety and safety culture.
Education
• University of Applied Science, Bachelor, Master or PhD in Biochemistry, Biology, Chemistry or Process Engineering (Biology, Chemistry).
Experience
• Several years (minimum 5 years) of practical experience and good knowledge in relevant fields, in particular plasma protein and purification of protein.
• Experience in process development, process improvements and manufacturing investigations.
• Experience with DoE methodologies and statistical data analysis.
• Experience in laboratory documentation, reporting and SOP management.
• Experience collaborating in cross-functional and scientific environments.
Competencies
• Strong scientific and technical expertise in plasma protein purification and fractionation processes.
• Ability to design, execute and document laboratory experiments and investigations.
• Knowledge of process development tools, methodologies and statistical data analysis.
• Strong collaboration and communication skills in an international environment.
• Ability to lead projects and contribute as Subject Matter Expert (SME).
• Strong organizational and documentation skills.
• Ability to train, guide and onboard laboratory staff.
• Continuous improvement and innovation mindset.
About CSL BehringCSL 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 and CSL Plasma at .
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL .
You Belong at CSL
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
Equal Opportunity Employer
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 .
Sprachkenntnisse
- English
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