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Cell Culture Manager

Expired
  • Salary: Negotiable
  • Job type: Permanent
  • Location: Offaly
  • Sector: Science
  • Date posted: 26/02/2018
  • Job reference: J375645A

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CELL CULTURE MANAGER

Our client, a leading pharmaceuticals company in Waterford, have an exciting opportunity for a Cell Culture Manager to join their growing team. 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 and upstream processes into cGMP facility.

Job description:

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.

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 studies
  • Provide 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.

Education/Experience:

  • PhD. 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

Skills/Competencies:

  • Must possess exceptional written and oral communication skills
  • Excellent knowledge of project management techniques and tools (e.g. MS Project)
  • Proven problem-solving capability with the ability to provide innovative/alternative approaches which meet business requirements in a compliant manner
  • Highly organized with a proven ability to prioritize and balance work from multiple projects in parallel
  • Able to build trust and respect as a manager of people, with a priority for the development of staff
  • Desire to learn and develop within the organization

For more information please contact Kathryn on 01 6455244 or email kathryn.whyte@experis.ie

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