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Team Horizon

Biologics Pharm Tech Scientist

Team Horizon

  • Mayo
  • Not disclosed
  • Fixed term contract
  • Updated 12/10/2017
  • Diarmaid Farrell
this job is expired
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Description

Team Horizon is looking to speak with a Biologics Pharm Tech Scientist for a leading Pharmaceutical company in the west of Ireland. This is a 9-month fixed term contract. This is an exciting opportunity to join a vibrant high-performing team.

 

The Opportunity

Team Horizon is looking to speak with a Biologics Pharm Tech Scientist for a leading Pharmaceutical company in the west of Ireland. This is a 9-month fixed term contract. This is an exciting opportunity to join a vibrant high-performing team.

The Role

  • Leading the DS2 Phase 3 project to ensure all deliverables are completed on time for Phase 3 manufacture in Q218.
  • Project lead and point of contact for meetings internally and external to site.
  • Review and Approval in an SME capacity of GMP documentation (e.g. SOPs, methods, Master records, Batch Records etc.).
  • Knowledge of analytical requirements will help facilitate a holistic view.
  • Support regulatory filing updates.
  • Work closely with Manufacturing, Analytical, Biologics Product Development (Irvine) and various site functions to ensure the project is delivered on time.

The Person

  • MSc degree with three years’ experience or a degree in a Science or Engineering discipline with five or more years of applied experience in Pharma/ Biologics
  • Experience with commercial & / or clinical manufacture
  • Excellent technical writing and communication skills.
  • Proven ability to problem solve.
  • People management skills essential
  • Biologics experience and understanding of bioanalytics an advantage (HPLC, ELISA, Western Blot etc.)
  • A good understanding of cleaning validation (specifically analysis of samples).
  • Participates in process and quality risk assessments.
  • Supports technology transfer activities.
  • Support NPI activities and lead various aspects to ensure all necessary processes and procedures are in place to be audit ready.
  • Experience with GMP regulatory inspections.
  • Experience with interacting in project teams at a local/global/corporate level
  • Good technical writing skills.
  • Excellent communicator.
  • Understanding of OPEX
  • Excellent planning and organisational skills.
  • Working knowledge of Quality Management System (QMS)
  • Knowledge of clinical development phases and associated requirements.

Ref: 518
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Team Horizon

Team Horizon

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