Senior Scientist

vor 1 Woche


Marburg an der Lahn, Deutschland CSL Behring Vollzeit

For our Plasma Product Development department we are looking for a

**Senior Scientist - Pilot Plant Marburg (M/F/x) - R-179640**:
(Fulltime / permanent/ tariff)

**Role**

**Main Responsibilities and Accountabilities**:

- Set up and handle all processes performed in facility, including design of new processes and process steps, connection systems, data recording, programming and handling of process equipment of all complexities
- Drive research projects as scientific coordinator or senior matter expert in research and development projects; Represent line as process expert
- Responsible for process-fit-analysis for pilot plant and implementation of measures and processes
- Window-person function to process development and operations; Coordination of project and study planning with other areas (e.g. process development, manufacturing, quality assurance, process engineering) or other sites
- Perform calculations to determine processes and define suitable equipment as well as consumables
- Lead execution of pilot scale campaigns on the floor in a cleanroom class C environment
- Global collaboration with other teams (Pilot Plants, R&D, operations, process engineering, Tech Transfer)
- Development and implementation of state-of-the art technologies and processes
- Recommend measures to improve production methods, equipment performance and quality of work and facilitate improvements/changes with a focus on innovation and work safety; Initiate and participate in continuous improvement activities and identification of relevant innovative technologies
- Technical preparation of decision bases for the procurement of new devices and systems (select relevant devices, create user requirements, participate in ordering, drive planning and execution of implementation and relevant qualification of technologies)
- Oversight of equipment maintenance, calibration, validation, qualification to assure compliance with demands
- Ensure that colleagues are familiar with processes and equipment
- Provide technical support for projects, change controls, risk assessments, deviations, CAPAs and audits; Support internal (self-) inspections providing technical input (German and English)
- Control and coordinate production activities, material flow and inventory
- Support and drive development and maintenance of procedural documents (SOPs), work instructions, process protocols and tools from a technical standpoint to ensure regulatory compliance, work safety and facility/process consistency (German and English)
- Write and review study plans and campaign reports as well as technical transfer documentation (German and English)
- Evaluation of experimental data and derivation of next steps
- Communication and presentation of results to the project team, management and department; Discussion of results with other areas (e.g. process development, manufacturing, quality assurance) or other locations
- Presentation of experimental results in internal and external meetings; contributions at congresses and preparation of publications
- Develop and implement policies and procedures to continually improve performance, quality, efficiency and work safety in pilot scale processes

**Experience in the following areas is an advantage**:

- Process development, process scale-up, manufacturing under GMP, process engineering
- Experience in working in cross-functional (global) projects and in an SOP regulated environment
- Understanding of the product development process and environment (functional/technical skills, analytical and problem solving mindset, creativity and flexibility)
- Knowledge of relevant protein purification methods
- Understanding of GxP requirements in the pharmaceutical industry
- High proficiency in English and German and good written and verbal communication skills

**Qualifications & Experience**:

- A University Degree in a relevant field of Science (e.g. Master of Science in biology, chemistry, biochemistry or pharmacology)
- English Level C; German Level B
- 1-3 years of relevant experience

**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.

**Do work that matters at CSL Behring**:



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