Senior Process Development Scientist

4 weeks ago


Dublin, Dublin City, Ireland Life Science Recruitment Full time
Senior Process Development Scientist
RK4114
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.

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

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

Duties:

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

Education and Experience:

1. Bachelor's degree in Analytical Chemistry/ Biochemistry or related discipline.
2. 3-6 years of relevant analytical experience in the Pharmaceutical Industry.
3. 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, Appearance/Colour/Clarity, CCI, Breakloose and Extrusion, RAMAN, FTIR, NIR, UV/VIS Spectrophotometry, SEM.
4. Experience with Chromatographic methods such as HPLC, UPLC, with UV, RID, Mass Spec detection would also be favourable but not essential.

If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.

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