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.
* 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