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Cell Culture Manager

Expired
  • Salary: Negotiable
  • Job type: Permanent
  • Location: Leinster
  • Sector: Science
  • Date posted: 23/01/2018
  • Job reference: J375645A

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Cell Culture Manager


Summary Of Role:


This is a lead role within the Process Development and Manufacturing group responsible for the development, optimisation, scale-up, characterisation, technology transfer and validation of cell culture / upstream processes into cGMP facility.

The candidate must have demonstrated broad knowledge base in routine mammalian cell culture, sterile technique, establishment of cell banks, and expansion of cell lines. In addition, the candidate will be responsible for authoring technical reports, protocols, technology transfer documents and CMC sections for regulatory filings. The candidate will be interfacing with team members in the maintenance, operation, and harvesting of bioreactors in a small-scale development facility and manage the cell culture team of process scientists. The candidate will be expected to interact on a routine basis with colleagues in downstream process development and analytical methods development and clinical groups. The candidate will be responsible for evaluating and implementing new technologies in the cell culture area.

Responsibilities:

  •  Build, lead and develop a team with expertise in biopharmaceutical process development, specifically in the area of upstream cell culture processes using disposable technologies
  • Develop, optimise, scale-up and validate all steps in the upstream process
  • Work with external service providers to ensure delivery of projects related to the upstream process
  • Manage technical transfer of site processes into the GMP production facility
  • Establish Batch Manufacturing Records, SOPs, and other quality system documentation to support GMP manufacture
  • Work closely with analytical development activities to support process development and process characterisation studiesProvide expert input into process validation programme, including, cell bank production and characterisation, cleaning validation, leachable studies
  • Manage production, supply and qualification of cell culture media and components
  • Provide support for other processing activities including purification and buffer
  • Support writing of relevant sections of CTD to support regulatory submissions
  • Participate in Quality and Safety regulatory audits
  • Identify continuous improvement initiatives and action plans to implement operational excellence and lean practices.

Preferred Qualifications:

  • Ph.D. in Chemical/Biochemical Engineering or related discipline with 5 years experience or B.S/M.S. in Chemical /Biochemical Engineering or related discipline with 7 - 10 years experience.