Position Purpose
Planning, execution, and evaluation of laboratory experiments and Scale-Down Model (SDM) studies for product and process optimization, to gain process knowledge and as part of root cause analysis in the investigation of deviations. Evaluation of data, creation of study reports and presentation of results in collaboration with our global partners. Responsibility for equipment comprising maintenance and training, including the drawing up of SOPs. Continuous improvement and renewal of laboratory equipment, laboratory infrastructure and laboratory processes. Evaluation and introduction of new technologies and equipment.
Main Responsibilities and Accountabilities
• Plan and conduct SDM experiments and analytical work in various deviation investigations, knowledge projects and global projects.
• Perform data analysis, drive troubleshooting, write reports and present data in cross-functional teams.
• 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.
• Support the team with different aspects of apprentice training program as needed.
• Comply with the relevant global quality systems (e.g. ELN, Veeva, HiDA, StarLIMS, SAP) and comply with them in accordance to GSP.
• Collaborate globally across different CSL sites and functions as and when applicable.
• Responsible for various equipment and provide training to team members.
• Suggest and implement continuous improvement in lab processes.
• Write and review (as subject matter expert) SOPs.
• Provide technical training to new staff and apprentices.
• Provide guidance to lower-level lab employees and apprentices.
• Search and apply literature in relevant area.
• Propose, evaluate, and drive introduction of new technologies and equipment.
Education
• Preferably EFZ (Laboranten Berufslehre), Bachelor or Master in Bioengineering, Biochemistry, Chemistry, or corresponding qualification based on work experience in a relevant field.
Experience
• Relevant technical discipline e.g., protein purification methods, precipitation, UF/DF, depth filtration. Preferably >5 years of hands-on practical experience.
• Knowledge in analytics e.g., FTIR, REM/EDX, SDS PAGE, Western Blot, HPLC is considered as an advantage.
• Experience in manufacturing process and development of biopharmaceuticals, process scale-up and/or scale down models, DoE methodologies.
• Fluent in German and English, both oral and written.
• Well versed in working with computerized processes and systems.
Competencies
• Strong laboratory and analytical skills in biopharmaceutical process development and troubleshooting.
• Ability to analyze data, prepare reports and present results in cross-functional teams.
• Knowledge of process optimization and root cause analysis methodologies.
• Strong collaboration and communication skills in an international environment.
• Ability to work independently and contribute to continuous improvement initiatives.
• Experience working with laboratory systems and computerized processes.
• Ability to provide technical training and guidance to team members and apprentices.
• Interest in evaluating and implementing new technologies and laboratory equipment.
About CSL Behring
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/.
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 https://www.csl.com/careers/inclusion-and-belonging
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 https://www.csl.com/accessibility-statement.
