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Job Description
A Senior Science Associate is required to provide Process Development support to a leading multi-national Pharma client based in Dun Laoghaire for a 12 month contract position.
**Role:**
* Provide Process Development support primarily to the Forensics and Defect Laboratory at ADL
* Establish expertise in forensic identification of Drug Product defects and maintain and produce extensive defect panels
* Ensure laboratory activity adheres to required policies and procedures, including safety and training
* Participate in cross functional teams to ensure adherence to required policies and procedures and deliver against organisational goals and project milestones
**Responsibilities:**
* Lead/assist forensic investigation and identification of defects arising from drug product manufacture at ADL
* Maintain, distribute 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
* 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 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
**Requirements:**
* Third level bachelor's degree in science, engineering or a relevant quality discipline
* 2-4 years' experience in a similar role OR Associate's degree and 5 years of directly related experience
* Experience in working in a laboratory environment
* Knowledge of cGMPs and other worldwide regulatory requirements
* Problem solving ability and excellent oral and written communications skills
* Experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as sterile processing, process characterisation, inspection, tech transfer or validation