About CSL BehringCSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, inherited respiratory disease, and neurological disorders. The company’s products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic disease of the newborn.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL; USOTC:CSLLY), headquartered in Melbourne, Australia, employs more than 22,000 people, and delivers its life-saving therapies to people in more than 60 countries. For inspiring stories about the promise of biotechnology, visit Vita at CSLBehring.com/Vita and follow us on Twitter.com/CSLBehring .
For our Recombinant Product Development department we are looking for a
(Fulltime / permanent)
- As a Scientist joining the Pilot Plant team within Recombinant Product Development, you will be responsible for upstream and downstream process development activities for a variety of therapeutic candidate proteins. This also encompasses the manufacture of materials for toxicological and early clinical studies. The successful candidate will have a hands-on approach while demonstrating a high level of technical competency within the team.
Main Responsibilities and Accountabilities:
- Have a hands-on approach and develop a strong understanding of the biotech industry's needs in terms of product quality and process-flow
- Demonstrate a successful track record of process development & technology transfer with a particular focus on USP
- Be familiar with regulatory and quality requirements including GSP, cGMP and QbD
- Understand and contribute to the adoption of new digital technologies particularly digital twins and process modelling
- Become familiar with Single-Use bioreactor systems and operate, maintain and improve other complex process equipment
- Drive Tech Transfer activities to scale up processes from lab scale to pilot scale
- Demonstrate relevant computer skills, with the ability to use statistical software packages and develop skills in statistical analysis and design of experiments
- Prepare materials for toxicological studies and early clinical development according to international regulatory guidelines and internal quality standards
- Ensure accurate and timely data collection and analysis in collaboration with other functions
- Author and review documents including procedures, experimental protocols, study plans and reports (German and English) including documents to support regulatory submissions and manufacturing
- Summarize, present and discuss respective studies, concepts and methods within the company, during regulatory audits and externally
Experience in the following areas is an advantage:
- Experience in aspects of recombinant protein manufacture and purification
- Experience in recombinant process development
- The ability to work collaboratively with upstream, downstream, formulation and analytical teams, also across global sites
- Three years’ experience in an upstream process development field
- It is an advantage to have industrial experience relating to purification process development, scale-up and validation of processes and GMP-manufacture
- Skills and experience associated with related process development disciplines and protein characterization are also valued
- Capabilities in the field of statistical and data analysis and experimental design
- 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. Bachelor of Science in biology)
- Project experience and knowledge of relevant analytical methods
- English Level 2
- 4-5 years of relevant experience
To allow us to treat your application with highest urgency we kindly ask you to apply online only via our career portal https://www.cslbehring.de/karriere to R-118934 indicating your salary expectation and notice period.
While applying for the job please refer to jobvector and use the following reference number: R-118934