Analytical Scientist

2 days ago

Dublin, Dublin City, Ireland Recruitment by Aphex Full time

Direct message the job poster from Recruitment by Aphex

Recruitment Lead | C&Q | Validation | Quality | Life Sciences Talent Specialist

This is an on-site Laboratory based role with responsibility for Analytical Support activities involving:

  • Analytical Method Troubleshooting,
  • Analytical Method Lifecycle (Development, Qualification, Validation, Remediation)
  • Analytical support for Process Development and Qualification activities at the site and wider network.

The successful candidate will have proven analytical experience acquired in the Pharmaceutical Industry, have a right first-time mindset, be a team player, have excellent communication skills and be focussed on delivering on our customer needs.

The successful candidate will also have a strong understanding of Data Integrity principles, Quality and Compliance in the laboratory as well as good presentation/influencing skills.

Additionally, the role may involve carrying out additional work functions that are not described in this specification but are associated with their role.

Key Responsibilities:

  • Analytical method troubleshooting, qualification, validation, bridging, transfer.
  • Analytical support for Process Development and Process Qualification activities
  • Act as support for the Attribute Sciences function on cross functional teams/programs
  • Timely documentation of Analytical data in the electronic notebook system.
  • Understanding of data flow in laboratory systems and data integrity.
  • Participate in the peer review of analytical data.
  • Compliance with Standard Operating Procedures for the Attribute Sciences Laboratory.
  • Ensure the laboratory is operated in a safe and environmentally friendly manner.
  • Ensure ongoing compliance with phase appropriate GMP, including compliance within the LMS training system.
  • Ensure high levels of Laboratory housekeeping are maintained including inventory control of samples and consumables.
  • Ensure timely completion of Laboratory Investigations, Deviations, PMAFs
  • Participate in internal/external audits/inspections as required.
  • Plan and implement procedures and systems to maximise operating efficiency.
  • Manage and contribute to the achievements of department productivity and goals.
  • Engage with the Continuous Improvement Process and MyGreenLab philosophy.

Qualifications:

  • Hold, at a minimum a third-level qualification (Degree) in Analytical Chemistry/ Biochemistry or related discipline.
  • Have 3-6 years of relevant analytical experience in the Pharmaceutical Industry

Knowledge and Experience:

  • Subject Matter Expert for General and Compendial methods used in the analysis of Drug Product 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
  • Experience with Chromatographic methods such as HPLC, UPLC, with UV, RID, Mass Spec detection would also be favourable but not essential.
  • Excellent written and verbal communication skills
  • Science based decision maker.
  • Experience with Regulatory inspections and interaction with inspectors is preferable.
  • Experience working with teams and influencing decisions.
  • Skilled in the use of problem-solving tools/techniques
  • Experience with developing, validating, troubleshooting, analytical methods.
  • Understanding of Process Validation activities (Engineering, PPQ, Comparability/Characterisation studies).
  • Understanding of the Change Control and Variation Management Process
  • Understanding how the use of statistical tools, such as multivariate analysis can aid troubleshooting.
  • Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating.
Seniority level

Associate

Employment type

Contract

Job function

Science

Industries

Pharmaceutical Manufacturing

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