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Downstream Process Scientist

Expired
  • Salary: Negotiable
  • Job type: Permanent
  • Location: Offaly
  • Sector: Science
  • Date posted: 26/02/2018
  • Job reference: J375647A

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Process Scientist - Biologics

Our client, a leading biologics organisation on the brink of launching a new range of biologics products based on their own technologies is currently interviewing to appoint a Process Scientist to contribute to the team and success of their organisation. This position requires people who want to be challenged, have a passion for success, and a constant drive to exceed expectations.

We are recruiting for an experienced Process Scientist with Upstream and/or Downstream Manufacturing experience to join a Biopharma manufacturing facility in the midlands.

Responsibilities:

  • Upstream Operations - Including Media Make-up, Inoculum Laboratory, Bioreactor Operations, Primary Recovery Operations
  • Downstream Operations - Including, Buffer Make-up, Chromatography, Nanofiltration, Tangential Flow Filtration, Drug Substance Bulk Filling
  • Operating process & equipment in a clean room environment, in accordance with batch record, user manuals, current standard operating procedures, safety requirements and GMP

  • Complete tasks required to meet production schedule and batch preparation including equipment set-up and cleaning, receiving and verification of all raw materials, filter integrity testing, running autoclave cycles, sampling, cleanroom housekeeping etc.
  • Assist with the development, review and up-dating of Batch Manufacturing Records, SOPs, and other quality system documentation to support GMP manufacture
  • Provide support for other processing activities including media and buffer preparation.
  • Process sampling and sample testing with analytical equipment, pH, conductivity, cell counting, and routine calibration of same
  • Completion of all relevant training on associated Individual Training Plans to complete manufacturing activities in a GMP manner. Provide training on process and equipment as required
  • Provide technical input during audits and also to present/ defend production systems, applicable change controls and deviations

Education/Experience:

  • BSc in a relevant discipline (e.g biochemistry, chemistry, process engineering) or equivalent GMP experience
  • Ideally 5 years relevant experience in bioprocess development and/or manufacturing, specifically on cell culture / bioreactor systems

Skills/Competencies:

  • Knowledge of FDA and EU regulations is desirable along with inspection experience
  • Strong background in mammalian cell culture and/or purification process unit operations and aware of the potential impact of equipment on biological molecules
  • Use of Unicorn, AKTA ready, disposable bioreactors, TFF systems an advantage
  • Process characterisation and process validation experience desirable
  • Good knowledge of GMP essential and excellent project management capability
  • Excellent verbal and written communication skills
  • Ability to maintain very clear records of work completed

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

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