Our client is one of the world's largest biotechnology companies. This is an excellent opportunity to join a market leader, and further develop your career with an innovative product development team.
This role will require the candidate to provide process development support primarily to the Forensics and Defect Laboratory. The candidate will establish themselves as an expert in forensic identification of Drug Product defects and maintain and produce extensive defect panels used to support automated and manual visual inspection of vial (liquid / lyophilised) and syringe packaged drug products.
• Leads / assists forensic investigation and identification of defects arising from drug product manufacture on site, 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 on site
• Working as part of the Product development 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.
You will report directly to Process Development Principal Engineer.
• Third level bachelor’s degree in science, engineering or a relevant quality discipline with 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.
• Masters in Science or Engineering.
• 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).
• Understanding of degradation mechanisms for biologics, analytical methods, laboratory practices, and basic statistical methods.
• Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
• Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
If you would like further Information you can contact the recruiter directly:
Kevin Silke | Tel: +353 (0) 1 507 9255