Senior Process Development Scientist
We are currently recruiting for an exciting opportunity with a leading Pharmaceutical organization based in Dublin.
This is an excellent position for anyone looking to join a multinational company that excels in their field.
The role is based in our on-site Laboratory and involves providing Analytical Support activities, including:
* Analytical Method Troubleshooting
* Analytical Method Lifecycle (Development, Qualification, Validation, Remediation)
* Analytical support for Process Development and Qualification activities at the site and wider network
Duties:
* Analytical method troubleshooting, qualification, validation, bridging, transfer
* Analytical support for Process Development and Process Qualification activities
* 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
* Participation 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
* Maintenance of high levels of Laboratory housekeeping, including inventory control of samples and consumables
* Timely completion of Laboratory Investigations, Deviations, PMAFs
* Participation in internal/external audits/inspections as required
* Planning and implementation of procedures and systems to maximize operating efficiency
* Management and contribution to departmental productivity and goals
* Engagement with Continuous Improvement Processes
Requirements:
* Bachelor's degree in Analytical Chemistry/Biochemistry or related discipline
* 3-6 years of relevant analytical experience in the Pharmaceutical Industry
* 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
* Experience with Chromatographic methods such as HPLC, UPLC, with UV, RID, Mass Spec detection would also be favorable but not essential