Senior Associate Scientist (Shift)
RK3443
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.



Duties:

• Leads / assists forensic investigation and identification of defects arising from drug product manufacture and write up of these investigations to cGMP standards.
• Be accountable for the maintenance, distribution and upkeep of extensive defect panels used for the set-up, training and characterisation of automated / semi-automated / manual finished drug product visual inspection equipment at.
• Working as part of the PD laboratory team be expected to contribute to upkeep / maintenance of a GMP laboratory environment.
• Provide process development expertise for commercial drug product particle / defect identification and contribute to the maintenance of local and global particle / defect libraries.
• Perform experiments, organise data and analyse results with minimal supervision (in a GMP laboratory environment) to evaluate product impact due to process variables encountered during drug product manufacture.
• Creation, Management and Maintenance of Inspection defect panels / sets.
• Execution of Knapp studies and data analysis.
• Establish experimental design, develop and implement protocols, obtain reproducible and reliable results and communicate data to cross functional groups.
• Ensuring all aspects of laboratory activity adheres to required policies and procedures, including safety and training.
• Ensure that the laboratory and site meet the quality requirements of its customers and applicable regulations (FDA, EU & international standards).
• Participate in cross functional teams at the site to ensure adherence to required policies and procedures and be responsible to deliver against organisational goals and project milestones.
• Assist in deviation and exception resolution and root cause analysis.

• Bachelor’s degree in a Science related field is required.
• 2-4 years of experience in the pharmaceutical industry,
• Experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as sterile processing, process characterization, inspection, tech transfer (to commercial DP sites) or validation.
• Be familiar with advanced microscopy (scanning electron microscopy) and spectroscopy (Fourier-transform infrared spectroscopy).