Job Description
Senior Associate Scientist (Shift)RK344312 MonthsDublinWe’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.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.Education and Experience: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).If interested in this posting, please feel free to contact Rachel Kent on +353 (0)87 427 8808 or rachel.kent@lifescience.ie for further information. #J-18808-Ljbffr