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.
