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?
We are looking for an experienced
Manager, Drug Substance Process Support
We are seeking personalities with the desire to contribute actively to the construction of the new production site. The position is reporting to the Director of DS Manufacturing and is responsible for leading the Drug Substance Manufacturing Support Team. This team is supporting the DS Manufacturing organization for process related topics (e.g. Tech Transfer, trouble shooting, data management and process improvement), for technical related topics (e.g. equipment design and optimization, control loops tuning) and for manufacturing automation related topic (e.g. manufacturing recipes (MES/PCS) creation and optimization, standardization and harmonization, training).
Main Responsibilities and Accountabilities:
Complete and develop the Drug Substance Manufacturing Support Team (about 7 people)
Works closely with DS Manufacturing organization to support the design, purchase and commissioning of DS manufacturing areas.
Works closely with the DS Manufacturing organization to support the qualification of the production equipment and areas.
Lead Technology Transfer activities to implement the manufacturing processes in the new facility.
Supports the PPQ preparation and execution for all recombinant products.
Support DS Manufacturing organization to specify, qualify and implement all necessary automation and business technology systems (MES, PCS, Historian, SAP, BMS, data management and others)
Work to optimize, trend, and report manufacturing process operational parameters during routine manufacturing campaigns, in close collaboration with the R&D colleagues.
Coordinate the support for manufacturing troubleshooting, process and equipment improvement initiatives.
Coordinate the support for automation manufacturing recipes standardization, trouble shooting and improvement.
Qualifications & Experience:
University degree (Uni, ETH or FH) in chemistry, pharmaceutical, biochemistry, technical or related field necessary
Minimum 10 years successful experience in biopharmaceuticals or another highly regulated industry in operations or/and technical functions required. Experience with technology transfer from an R&D organization would be an advantage.
Depth knowledge of recombinant protein production or related field required
Experience with Process Control System (PCS) and Manufacturing Execution System (MES) specification, implementation and use.
Knowledge of ISA 88 standard preferred
Excellent communication and organization skills
Very good command of German and English
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
The position might require some travel (up to 20%)
Are you motivated to join this exciting journey and help us establish a state of the art biopharma manufacturing facility?
Offices will be in Lengnau.
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.