Bitte beziehe Dich bei der Bewerbung auf jobwinner.ch
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 Lengnau AG is part of CSL’s ongoing global expansion strategy to support the company’s long-term growth plans.
The new plant in Lengnau with its highly advanced facilities will manufacture innovative and promising therapeutics with the aim to enhance the quality of the patient’s lives. One of the main products will be a recombinant coagulation factor to treat hemophilia B patients.
The Lengnau site project generates an investment of approximately a billion Swiss Francs and will create around 300 new jobs when it is fully operational.
Are you interested in being part of this exciting project?
We are looking for an experienced
Senior Manager, Fill Finish Operations
We are seeking personalities with the desire to contribute actively to the construction of the new production site. This position is responsible for supporting the Head of Fill Finish in leading and managing an aseptic filling suite and three freeze dryers by using isolator technology.
Main Responsibilities and Accountabilities
During the Project Phase:
Supports definition of routine processes for final bulk formulation, CIP/SIP, sterile filtration, aseptic filling, freeze drying, CCIT, Visual Inspection and hygiene concept.
Supports definition of automation requirements (MES, EBR, Monitoring and others) and collaborates with BOS, Engineering and Quality to implement the necessary information systems.
Works closely with the Project Management Organization to support the commissioning of the production equipment in accordance with process requirements and compliant with applicable cGMP requirements.
Works closely with the Quality and Engineering organization to support the qualification of the fill finish production equipment (CVQ)
Supports the PPQ execution for the fill finish processes.
During Commercial Operations Phase:
Supports the Fill Finish Area Lead in production planning and managing the aseptic filling suite and freeze drying area at commercial scale capacity.
Is responsible for creating and updating the electronic manufacturing procedures and recipes within the MES.
Build cross functional teams and interact with other support functions such as Quality Assurance, Quality Control, Manufacturing, Engineering, , Validation, and other relevant functional areas.
Supports training and qualification of operators
Qualifications and Experience:
Bachelor degree required preferably in chemistry, biochemistry, pharmaceutical, technical or life-science field
Master degree or PhD preferred in chemistry, biochemistry, pharmaceutical, technical or life-science field (MSc or equivalent)
In depth knowledge of cGMP’s of aseptic processing required.
Speak and write proficiently in German and English languages.
3 – 5 years’ experience in a cGMP regulated production environment (pharmaceutical or biotech industry).
Intermediate to strong working knowledge of Microsoft Office products.
Proven ability to work in a fast paced, dynamic environment.
Learn new processes and quickly engage in assignments to drive for action.
Makes decisions in accordance with established policies and procedures.
Are you motivated to join us in this exciting journey to establish a state of the art pharma manufacturing facility with most advanced technologies?
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.
CSL Behring is committed to provide equal employment opportunity for all.