vor 8 Tagen

Senior Manager, Media & Buffer Processing

1094 CSL Behring Rec. Fac. AG

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Senior Manager, Media & Buffer Processing

Senior Manager, Media & Buffer Processing

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

Senior Manager, Media & Buffer Processing

We are seeking personalities with the desire to contribute actively to the construction of the new production site. The position is responsible for supporting the Director, Manufacturing Support in leading and managing Media & Buffer preparation lines in the Lengnau Recombinant Facility.

Main Responsibilities and Accountabilities:

During the Project Phase:

  • Works closely with the Project Management Organization to support the design, purchase and commissioning of Media & Buffer Preparation/Storage areas including 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 Media & Buffer Preparation/Storage equipment.
  • Participates in Technology Transfer activities to implement the preparation and storage of Media & Buffers in the new facility.
  • Supports the PPQ execution for the Media & Buffer process.
  • Is responsible to collaborate with BT, Engineering and Quality to specify, qualify and implement all necessary information systems for the production area within the field of responsibility (MES, Historian, SAP, BMS and others)
  • Supports the setting-up of production teams, ensuring the proper integration and training of new employees.
  • Ensures that HSE requirements are integrated in all aspects of the project

Commercial Operations Phase:

  • Is responsible for the daily operations of a Media and/or Buffer preparation and storage suite at commercial scale capacity.
  • Performs manufacturing level maintenance on equipment.
  • Analyses samples using simple techniques such as pH, osmolality and conductivity.
  • Gathers, trends, and analyses process generated data.
  • 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 the R&D colleagues.
  • Build cross functional teams and interact with other support functions such as Quality Assurance, Quality
  • Control, Manufacturing Engineering, MTS, Validation, and other relevant functional areas.
  • Is responsible for the on-going facility readiness to health authorities inspection

Qualifications & Experience:

  • University degree (Uni, ETH or FH) in chemistry, pharmaceutical, biochemistry, technical or related field necessary
  • Knowledge of ISA 88 standard preferred
  • Minimum 5 years successful experience in pharmaceuticals or another highly regulated industry in operations functions required.
  • Experience with technology transfer from an R&D organization would be an advantage.
  • Depth knowledge of recombinant protein production, blood industry or related field required
  • Excellent communication and organisation 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 a substantial amount of travel in the initial project phase (up to 50%). This will be substantially diminished after the commissioning phase.

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. For initial information you are welcome to contact HR Operations, at +41 31 344 12 14.

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