JO-2412-545422
Our client, API manufacturing facility in Dublin, requires an experienced Chromatography Specialist to join their R&D team supporting projects from early clinical phases through to commercial production. A strong technical background in preparative chromatography in lab and pilot lab scale is essential
Role
• Collaborate with a team of R&D chemists to scale up development projects in the laboratory. This may include development, completion of proof-of-concept studies in the kilo lab, isolation, and process safety assessments as required.
• Perform analytical and preparative purifications of research materials to support process development.
• Execute achiral and chiral purification of pharmaceutical compounds and isolation of impurities.
• Evaluate and develop separation conditions through solubility, loading, and stability studies at mg to g scale.
• Conducts scaleup demonstrations of separations at multi g scale.
• Execute early deliveries of 100’s g to kg scale in conjunction with our process R&D team.
• Maintain lab presence and be actively involved in lab work.
• Analyze and interpret scientific results.
o Author scientific reports and present work as needed.
• Initiate and champion new technology’s introduction.
o Ensure that the chromatography equipment is qualified and ready for batch manufacture.
o Build and maintain contacts with representatives of equipment and material suppliers.
o Initiate and foster collaboration with external research institutes, companies, and universities.
o Keep up-to-date knowledge on purification related technologies.
o Represent department in cross-functional working groups.
• Conduct your work within the predefined safety, environmental and quality standards.
• Create Master Batch records for Chromatography.
• Collaborate with R&D chemists to ensure that process development operations demonstrated in the laboratory can be implemented successfully in the GMP kilo plant.
• Collaborate with project engineering and R&D team to build the capabilities within GMP kilo lab facility and bring new technology on site.
• Improve and develop current chromatography offerings.
• Run Kilo lab scale GMP manufacture in our GMP kilo lab alongside operations and R&D colleagues.
• Collaborate with R&D project leads, project management group, and other functions such as SHE, Operations and Quality to ensure that project milestones are delivered as per the project plan.
• Collaborate with customers in development projects to ensure that the final process taken to the manufacturing plant is understood, robust, efficient, in-control and meets their expectations.
Experience :
• Strong technical background in preparative chromatography in lab and pilot lab scale
• PhD or Master’s degree with specialization in chemistry/ engineering or related discipline.
• In depth knowledge and technical proficiency in preparative chromatography, HPLC and related techniques.
• Experience with chemical process development, scale-up and GMP manufacturing with emphasis on chromatographic purification.
• Experience in both low pressure (flash) as well as high pressure (prep) chromatography
• Experience in troubleshooting and Clinical batch manufacture in a GMP environment.
• Demonstrated capability in the use of standard tools for root cause analysis and standard statistical tools.
• Experience in Freeze drying or Tangential flow filtration.
• Use of glass reactors at kilo lab scale or experience in integration of chromatography into an API plant
• Experience with Gloveboxes and/or flexible isolators
• Experience with equipment validation
