CSL Behring is a leading global biotherapeutics company committed to its promise to save lives. The parent company, CSL Limited, is headquartered in Melbourne, Australia.
In May 2014, CSL selected Lengnau in the Canton of Bern in Switzerland as the location of a new manufacturing facility to support the commercial production of our promising novel therapies.
The CSL Behring Recombinant Facility (RCF) in Lengnau is part of CSL's ongoing global expansion strategy to support the company's long-term growth plans.
The new plant in Lengnau will manufacture three recombinant coagulation factors to treat hemophilia A & B patients. For one of these products we have already received marketing approval, for the second product we expect global market launch this year. The Lengnau site project generates an investment of several hundred millions USD and will create around 300 new jobs when it is fully operational in 2019/2020.
Are you interested in being part of this exciting project?
For our location in Lengnau (BE), we are looking for a talented and highly enthusiastic:
QA release Scientist
Joining the QA Release team you would have the unique opportunity to provide your personal contribution to the design and development of future product release processes.
Main Responsibilities and Accountabilities:
During the period of establishing the new manufacturing site, the position holder will be part of the facility program and will have to support the implementation of the necessary systems within the facility.
As part of the Quality Release team of CSL Behring Recombinant Facility in Lengnau (LGN), the position holder is responsible to perform QA review of batch release related tasks for the recombinant coagulation factors such as:
Review and approve the operational elements such as Policy and SOPs, and any other procedural document as applicable.
Review and approve paper/electronic batch records for drug substance production (up- and downstream) as well as filling (Drug Product) and packaging operations.
Draft, review and approval, as applicable, material specification documents.
Support, on demand, the SAP implementation project during SAP test phase
Qualifications & Experience:
3 to 5 years in a biotech company or in aseptic filling within the pharmaceutical industry and not less than 1 years in the Quality Assurance area
Knowledge of pharmaceutical manufacturing process with particular focus on Biologic Drug Substance and Aseptic filling.
Experience in Master Batch Record/Executed batch record review, batch release and specification documents review is an asset.
Good proficiency in German and English is required.
Experience in SAP is an asset.
We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.
Offices will be in Stöckacker, Bern, and later in Lengnau.
CSL Behring is committed to provide equal employment opportunity for all.