Scientist - Pilot Plant UFDF SME - #869673

For our PPD Pilot Plant Facility, we are looking for a

Scientist - Pilot Plant UFDF SME (m/f/x)

Fulltime / permanent/ tariff

R-229717

The Opportunity

You will be part of the PPD Pilot Plant team and contribute to manufacturing of materials relevant for a variety of studies during process development activities for new and optimized plasmatic manufacturing processes. Your main responsibilities include the optimization of process set-ups and workflows to ensure process conditions with optimized comparability to full-scale routine manufacturing.

You will not only be involved in establishing new processes, but also support identification of new pilot scale equipment, optimization of process parameters and drive increase of efficiency in process workflows.

The Role

• Your main responsibility in this role will be the planning, manufacturing and data analysis of batches within the Plasma Product Development Department.
• You will join cross-functional teams on a local and global level and present/coordinate activities relevant for manufacturing of Pilot Scale Batches.
• During Tech-Transfer and Process Implementation you will join as SME for Ultra-/Diafiltration applications/process steps and function as point of contact for process related questions for the respective UFDF unit operations.
• As SME for specific process steps and devices you will gather/analyze information/data and furthermore work closely with internal/external suppliers and collaboration partners
• Furthermore, creation and maintenance of material requirement lists, inventory management and generation of supply/demand calculations are a fundamental part of your role
• You will support the creation and maintenance of records and technical documents (including batch protocols, Pilot Scale process designs, operating procedures, test- or process protocols and reports) within internal documentation systems and contribute to the submission of regulatory documents.
• You will perform trainings and contribute to risk assessments as well as evaluation of variations which ultimately will help to define CAPAs.
  
  

Your Skills And Experience

• A University Degree in a relevant field of science (e.g. Bachelor of Science in biology, biochemistry or protein chemistry)
• 4-5 years of relevant post graduate experience
• Professional experience in Plasma Product Development (Down-, Kilo-, Pilot-, Full-scale processes)
• Excellent communication and presentation skills in English
• Technology transfer into pilot scale operations (e.g. Process Designs, Parameters lists etc.)
• Inventory/Demand Management in regulated manufacturing facilities (e.g. buffers and other raw materials)
• GxP compliance (e.g. documentation and (Tox/Stability/Clinical) manufacturing)
• UFDF excellence (Designing & establishing complex equipment set-ups, trouble-shooting and definition of mitigations for process variations)
• 5S practices
  
  

What We Offer

• CSL-subsidized company bike leasing
• Childcare “Kita Froschkönig” for up to 14 children (from 6 months till 3 years old)
• Access to Gym facility on campus
• 2 Wellness days per year (additional paid time off)
• Family services such as psychological support, legal advisory, family care services and more for you and your direct family
  
  

For more information, please check out our global benefits below.

We are looking forward to your application. Please ensure to apply online with your CV and certifications as well as your salary expectation.

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

We want CSL to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

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