Senior Scientist Albumin

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.