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Analytical Expert Associate

1 week ago

Dublin, Dublin City, Ireland PE Global Full time

PE Global is currently recruiting for a Senior Associate in Dublin.

Senior Recruitment Consultant @ PE Global | Recruitment Consultant Science & Engineering

This position involves contract work.

Key Responsibilities:
  • Troubleshoot, qualify, validate, bridge, and transfer analytical methods.
  • Support Process Development and Process Qualification activities with analytical expertise.
  • Work collaboratively with Attribute Sciences teams/programs.
  • Document analytical data in electronic notebooks accurately and timely.
  • Understand laboratory data flow systems and maintain data integrity.
  • Participate in peer reviews of analytical data.
  • Maintain compliance with laboratory Standard Operating Procedures.
  • Ensure the laboratory operates safely and sustainably.
  • Comply with phase-appropriate GMP guidelines, including training within LMS.
  • Maintain high laboratory standards, including inventory control of samples and consumables.
  • Complete Laboratory Investigations, Deviations, PMAFs efficiently.
  • Participate in internal/external audits/inspections as required.
  • Develop and implement procedures to optimize laboratory efficiency.
  • Contribute to department productivity and goal achievement.
  • Engage with Continuous Improvement Process and MyGreenLab philosophy.

Requirements:

  • Hold a third-level qualification (Degree) in Analytical Chemistry/Biochemistry or related field.
  • Have 3-6 years of relevant analytical experience in the Pharmaceutical Industry.
  • Be subject matter expert in General and Compendial methods for Drug Product analysis, such as Sub Visible Particle Analysis, KF Moisture, pH, Osmolality, Density, App/Colour/Clarity, CCI, Breakloose and Extrusion, RAMAN, FTIR, NIR, UV/VIS Spectrophotometry, SEM.
  • Familiarity with Chromatographic methods like HPLC, UPLC, with UV, RID, Mass Spec detection would be beneficial.
  • Demonstrate excellent written and verbal communication skills.
  • Makes science-based decisions.
  • Experience with Regulatory inspections and interaction with inspectors is preferred.
  • Proven ability to work with teams and influence decision-making.
  • Skilled in problem-solving tools/techniques.
  • Experience developing, validating, and troubleshooting analytical methods.
  • Understanding of Process Validation activities, Engineering, PPQ, Comparability/Characterisation studies.
  • Understanding of Change Control and Variation Management Processes.
  • Awareness of statistical tools, multivariate analysis aiding troubleshooting.
  • Possess planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating competencies.