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R&D Sterile Process Lead

Expired
  • Salary: Negotiable
  • Job type: Permanent
  • Location: Waterford
  • Sector: Science
  • Date posted: 26/02/2018
  • Job reference: J380132A

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R&D STERILE PROCESS LEAD

Our client, a leading pharmaceuticals company in Waterford, have an exciting opportunity for an R&D Sterile Process Lead to join their growing R&D Team. This position offers an impressive and unique opportunity for interested candidates. This position requires people who want to be challenged, have a passion for success, and a constant drive to exceed expectations.

Job description:

The R&D Sterile Process Lead will be responsible for coordinating activities of personnel engaged in cleaning, sterilizing, assembling and distributing of sterilized instruments and equipment. The lead will assist the Sterile Processing Technicians to help ensure that all policies and procedures are followed, and assists Supervisor with annual staff evaluations, as well as assisting with ordering needed supplies and instruments for department.

Responsibilities:

  • Supporting the R&D Department by providing significant fill-finish technical expertise to support all aspects of the manufacturing of sterile products.
  • Provide leadership, cross-functional development, and technical expertise on the aseptic manufacture of biologics.
  • SME for introduction of single use systems and assessment of their use in terms of extractables, leachables and container closure.
  • Identify and then lead process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing.
  • Responsible for ensuring availability of knowledge, information, expertise and training as needed for the activities necessary to execute the transfer and all testing to support the Technology Transfer process, as relevant to the Receiving Unit.
  • Technical protocol and summary report generation as related to technical studies executed in direct support of GMP manufacturing activities.
  • Identify manufacturing best practices across the network and lead or participate in teams to implement best practices.
  • Oversee execution of technical studies and associated document preparation at the receiving unit.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.

Education/Experience:

  • Qualified to a minimum of degree level in an appropriate science or engineering discipline, preferably biotechnology.
  • 5 years' experience working in relevant unit operations including mixing, formulation, sterile filtration, sterilisation, aseptic processing, component processing technologies, liquid filling, and visual inspection.

Skills/Competencies:

  • Must possess exceptional written and oral communication skills allowing direct interaction with all key project stakeholders
  • Excellent knowledge of project management techniques and tools (e.g. MS Project)
  • Customer relations management (internal & external)
  • Multi-tasking, ability to manage conflicting deadlines
  • Excellent written, oral, interpersonal and presentation skills
  • Excellent computer skills to include MS office, ECDL certification an advantage
  • Proven time management, planning & organizing skills
  • Knowledge of electronic document management systems

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

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