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Process Expert USP/DSP Operations

1094 CSL Behring Rec. Fac. AG

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Process Expert USP/DSP Operations

Process Expert USP/DSP Operations

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 and will 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. Two of these products have already received marketing approval, and we expect global market launch for the third product in 2020. The Lengnau site project is 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

Process Expert, USP/DSP Operations

We are seeking talents with the desire to contribute actively to the construction of the new production site. Initially, for about a 12-month period, the Process Expert will be travelling (up to 50%) to internal manufacturing sites or to CMOs to learn and gain experience on processes that will be later transferred to Lengnau. Process expert will also be involved into FAT of manufacturing equipment. After this initial phase, the Process Expert will be mainly based in Lengnau, Switzerland, to support USP and/or DSP facility qualification and start-up, as well as the technology transfers of all required manufacturing processes.

Main Responsibilities and Accountabilities:

During the Project Phase:

In CSL existing manufacturing facilities and/or CMOs:

  • Gains recombinant coagulation factor manufacturing knowledge in our existing manufacturing facilities and at our CMOs.
  • Works with Process Development to develop expertise in raw material pre-screening, small scale model qualification and other process improvement initiatives.

In Lengnau:

  • Supports the design, production equipment procurement and commissioning of manufacturing areas in accordance with process requirements and compliant with all applicable cGMP requirements.
  • Perform and support the creation of manufacturing recipes within the Manufacturing Execution System (MES).
  • Works closely with the Quality and Engineering organization to support the qualification of the manufacturing areas including production equipment.
  • Participates in Technology Transfer activities to implement recombinant protein manufacturing processes in the new facility.
  • Supports the PPQ execution.

Commercial Operations Phase:

  • Participates in the manufacturing of recombinant coagulation factors
  • Participates in defining robust process parameters during routine manufacturing campaigns.
  • Works to optimize, trend, and report manufacturing process operational parameters during routine manufacturing campaigns, in close collaboration with R&D colleagues.
  • Performs manufacturing troubleshooting, process improvement initiatives so as process development studies.

Qualifications & Experience:

  • University degree (ETH or FH) in chemistry, pharmaceutical, biochemistry, technical or related field necessary
  • 3-5 years' experience in biopharmaceuticals process development or in technical operations functions required. Experience with technology transfer from an R&D organization would be an advantage.
  • Good knowledge of recombinant protein production or related field required
  • Knowledge of ISA 88 standard preferred
  • Very good command of German and English
  • 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
  • During the initial project phase, the position will require a substantial amount of travel to gain process knowledge and to support equipment testing, in suppliers facilities, before shipment to Lengnau (up to 50%). This will be substantially diminished after the commissioning phase.

Are you motivated to join this exciting journey and help us establish a state of the art biopharma manufacturing facility?

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. For initial information you are welcome to contact Recruitment, at +41 31 344 12 51.

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