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Manufacturing Technology Scientist

  1. Dublin
Dublin
  1. Contract
Competitive
  1. CAPEX Projects
07-10-2019
23475CT

This vacancy has now expired

One of the top 10 best companies to work for in Ireland is looking for a Manufacturing Scientist for their large scale new facility north of Dublin. Is this you?

Our client has built a new state-of-the-art Multi-Product Cell Culture biologics manufacturing facility in Dublin, approximately a $1 billion investment. Once commissioned, the new facility will significantly increase their biologics manufacturing capacity and play a central role in its global manufacturing network.

Key Responsibilities:
  • Supports process technology transfer, process validation and the preparation of CMC documentation for regulatory filings for the Multi Product Cell Culture facility
  • Investigation and resolution of process deviations, root cause investigations, CAPAs, process improvements, change controls and preparation of regulatory filings
  • Strong knowledge of cGMP compliance, corporate, site and regulatory agency requirements.
  • Assists in evaluating process performance by comparing manufacturing data to historical data from other sites
  • Authoring of technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing process
  • Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies, representing the site
 This job might be for you if:
  • Minimum BSc or equivalent with at least 4 years’ experience in cell culture or purification manufacturing technical support in the biopharmaceutical industry including experience with process validation
  • You have demonstrated awareness of cGMP compliance and regulatory agency requirements as well as strong oral communication and technical writing skills
  • Excellent verbal & written communications skills. Interpersonal and facilitation skills necessary to interface with and influence all levels of the organization with the ability to lead people and multi-disciplinary teams
  • You have proven problem solving ability, project management skills, including leading cross functional teams and balancing multiple project assignments
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