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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Senior Associate Scientist - Forensics and Defect Laboratory (Shift)


Reference:RK2806 Location: Dublin
Qualification:DegreeExperience:2-3 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Food Scientist, Scientist

Senior Associate Scientist - Forensics and Defect Laboratory (Shift)
RK2806
12 Months
Dublin


We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


Duties:

  • Leads / assists forensic investigation and identification of defects arising from drug product manufacture and write up of these investigations to cGMP standards.
  • Be accountable for the maintenance, distribution and upkeep of extensive defect panels used for the set-up, training and characterisation of automated / semi-automated / manual finished drug product visual inspection equipment.
  • Working as part of the PD laboratory team be expected to contribute to upkeep / maintenance of a GMP laboratory environment.
  • Provide process development expertise for commercial drug product particle / defect identification and contribute to the maintenance of local and global particle / defect libraries.
  • Perform experiments, organise data and analyse results with minimal supervision (in a GMP laboratory environment) to evaluate product impact due to process variables encountered during drug product manufacture.
  • Creation, Management and Maintenance of Inspection defect panels / sets.
  • Execution of Knapp studies and data analysis.
  • Establish experimental design, develop and implement protocols, obtain reproducible and reliable results and communicate data to cross functional groups.
  • Ensuring all aspects of laboratory activity adheres to required policies and procedures, including safety and training.
  • Ensure that the laboratory and site meet the quality requirements of its customers and applicable regulations (FDA, EU & international standards).
  • Participate in cross functional teams at the site to ensure adherence to required policies and procedures and be responsible to deliver against organisational goals and project milestones.
  • Assist in deviation and exception resolution and root cause analysis.

Education and Experience :
  • Third level bachelor’s degree in science, engineering or a relevant quality discipline with 2 - 4 years’ experience in a similar role OR Associate’s degree and 5 years of directly related experience.
  • Experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as sterile processing, process characterization, inspection, tech transfer (to commercial DP sites) or validation.
  • Be familiar with advanced microscopy (scanning electron microscopy) and spectroscopy (Fourier-transform infrared spectroscopy).

If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or [email protected] for further information.