vor 15 Tagen

Senior Manager, Manufacturing Support

1094 CSL Behring Rec. Fac. AG

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Senior Manager, Manufacturing Support

Senior Manager, Manufacturing Support

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

Sr. Manager, Manufacturing Support

This position is responsible for supporting the Director, Manufacturing Support in leading and managing Media & Buffer production/storage and Equipment Preparation lines in the Lengnau Recombinant Facility. The position requires a manager with scientific background and experience in running relevant pharmaceutical operations (powders handling, mixing, dissolution, sterile filtration, washing and steam sterilization) as well as working effectively in a cross functional team and leading manufacturing teams. During the period of establishing the new manufacturing site the position holder will be part of the facility program and implement the necessary systems within the facility. In particular the position holder will be involved to design and establish processing equipment, flows and procedures necessary for the supporting areas and to create the electronic batch record system within the area of responsibility.

Main Responsibilities and Accountabilities:

  • Support the establishment of an operational Manufacturing Support department of the CSL Behring Recombinant Facility AG site.
  • Recruit and train the personnel
  • Able to work effectively in matrix and priority changing organization
  • Lead by example and promote a living culture of the CSL / CSL Behring Recombinant Facility AG values in the Manufacturing Support department

    Technical Duties

  • Ensuring of a GMP-compliant production within his field of activity
  • Development and approval of written instructions for his/hers field of activity and ensuring of their strict compliance
  • In collaboration with QA team, ensures presentation of all batch records / deviations / changes for validation material during Pre-Approval Inspections
  • SME / Review of submission files for area of responsibility
  • Write and Review URS, FS and P&IDs to ensure production needs are met
  • Define adequate control strategy aligned with QbD principles and criticality of process attributes and parameters
  • Selection of equipment, FAT/SAT
  • Support the development and execute IOPQ and CV protocols

Qualifications & Experience:

  • Bachelor Degree required preferably in engineering, chemistry, pharmaceutical, biochemistry, technical or related field, Master degree would be an asset
  • Minimum 5 years successful experience in pharmaceuticals or another highly regulated industry in relevant operations functions required (powders handling, mixing, dissolution, sterile filtration, washing, steam sterilization) required
  • Experience in leading a team required
  • Experience with technology transfer from an R&D organization would be an advantage
  • Experience in large scale manufacturing would be an advantage
  • Speak and write proficiently in German and English
  • 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?

Offices will be in Stöckacker, Bern, and later 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. For initial information you are welcome to contact Recruitment at +41 31 344 12 51.

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