• Cork

Initial 12-month contract role.

Position Summary

The position is in the Drug Product Sciences (DPS) Lab Team which sits within the Analytical Operations Group as part of the wider BTDS AD Department.

Core responsibilities are analytical laboratory testing of large molecule products from Tox to Phase 3 by the following techniques:

  • Compendia Testing (pH, Colour, Turbidity, Moisture and Osmolality Analysis).
  • Particulates Testing (Microflow Imaging, Light Obscuration Sub-Visible and Visible Foreign Analysis).

Main duties and responsibilities

  • Ensure that EHS standards are always met on site, adhering to appropriate PPE and COVID-19 measures and guidance
  • Maintain Lab cleanliness standards to ensure Lab is always audit ready in line with Lab 6S Program
  • Ensure Training is completed in a timely fashion. In time, assist in the training/ mentoring of new Analysts
  • Perform Analytical testing for the DPS Team in BTDS AD Cork in line with the above-mentioned techniques including all peripheral activities (i.e. solution prep)
  • Perform data review, interpretation, and trending of data
  • Contribute to proper use, calibration, and maintenance of laboratory equipment where applicable.
  • When required, Participate/coordinate activities in relation to External Outsourcing, such as following up with ECLs on Analytical Testing, Approving/Reviewing Investigations, Raising PO’s, Authoring Quality Agreements, Creating/Assessing Change Controls.
  • Keep up to date with existing and new SOP’s and official documentation.
  • Independently write/revise SOP’s or other official documentation and reports, when required.
  • Participate/Lead in Laboratory investigations as applicable
  • Escalation of Laboratory issues to team lead in a timely fashion
  • Perform other duties as designated by Team Lead
  • Take an active role in Continuous Improvement, identify and drive improvement initiatives in line with Laboratory CI Team

Education and Experience/Competencies

  • A level 8 qualification in a Biochemistry, Biotechnology, or a related scientific field.
  • Customer focus and result driven.
  • Analytical skills required to troubleshoot laboratory issues.
  • Efficient and flexible.
  • Excellent communication skills.
  • Proficient in the use of business applications such as MS PowerPoint, MS Word and MS Excel
  • Ability to think logically, proactive approach.
  • Ability to work on own initiative.
  • High attention to detail.
  • Ability to work well within team structures and provide leadership as required.

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