34114-Analytical Scientist-Dublin Contractor

This is a 12-month initial contract .

Purpose:

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.

 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 maximize 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.