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Sterile Process Lead

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Munster
  • Sector: Science
  • Date posted: 24/05/2018
  • Job reference: J386991A

Sterile Process Lead

The role is to provide scientific/engineering leadership across all the disciplines involved in Technology Transfer and Sterile Operations. This role would suit candidates with biotechnology academic attainments, at least 5 year's experience in working within sterile operations/tech transfer and fill finish manufacturing.

Responsibilities

  • Provide scientific/engineering leadership across all the disciplines involved in Technology Transfer and Sterile Operations
  • SME for introduction of single use systems and assessment of their use in terms of extractables, leachables and container closure
  • SME for sterile formulation of biologic products
  • Support all aspects of the manufacturing process from formulation and filling to visual inspection
  • Technical review of change controls for impact to product quality, safety and efficacy

Requirements

  • Provide scientific/engineering leadership across all the disciplines involved in Technology Transfer and Sterile Operations
  • SME for introduction of single use systems and assessment of their use in terms of extractables, leachables and container closure
  • SME for sterile formulation of biologic products
  • Support all aspects of the manufacturing process from formulation and filling to visual inspection
  • Technical review of change controls for impact to product quality, safety and efficacy

For more information on this and other opportunities, please call Kathryn for a confidential chat on 016455250