JO-2412-545422
Our client, an 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
1. Collaborate with a team of R&D chemists to scale up development projects in the laboratory, including development and completion of proof-of-concept studies in the kilo lab, isolation, and process safety assessments.
2. Perform analytical and preparative purifications of research materials to support process development.
3. Execute achiral and chiral purification of pharmaceutical compounds and isolation of impurities.
4. Evaluate and develop separation conditions through solubility, loading, and stability studies at mg to g scale.
5. Conduct scaleup demonstrations of separations at multi g scale.
6. Execute early deliveries of 100’s g to kg scale in conjunction with the process R&D team.
7. Maintain lab presence and be actively involved in lab work.
8. Analyze and interpret scientific results.
9. Author scientific reports and present work as needed.
10. Initiate and champion new technology’s introduction, ensuring that the chromatography equipment is qualified and ready for batch manufacture.
11. Build and maintain contacts with representatives of equipment and material suppliers.
12. Initiate and foster collaboration with external research institutes, companies, and universities.
13. Keep up-to-date knowledge on purification related technologies.
14. Represent the department in cross-functional working groups.
15. Conduct work within predefined safety, environmental, and quality standards.
16. Create Master Batch records for Chromatography.
17. Collaborate with R&D chemists to ensure that process development operations demonstrated in the laboratory can be implemented successfully in the GMP kilo plant.
18. Collaborate with project engineering and R&D team to build capabilities within GMP kilo lab facility and bring new technology on site.
19. Improve and develop current chromatography offerings.
20. Run Kilo lab scale GMP manufacture in the GMP kilo lab alongside operations and R&D colleagues.
21. 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.
22. 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
1. Strong technical background in preparative chromatography in lab and pilot lab scale.
2. PhD or Master’s degree with specialization in chemistry/engineering or related discipline.
3. In-depth knowledge and technical proficiency in preparative chromatography, HPLC, and related techniques.
4. Experience with chemical process development, scale-up, and GMP manufacturing with emphasis on chromatographic purification.
5. Experience in both low pressure (flash) as well as high pressure (prep) chromatography.
6. Experience in troubleshooting and Clinical batch manufacture in a GMP environment.
7. Demonstrated capability in the use of standard tools for root cause analysis and standard statistical tools.
8. Experience in Freeze drying or Tangential flow filtration.
9. Use of glass reactors at kilo lab scale or experience in integration of chromatography into an API plant.
10. Experience with Gloveboxes and/or flexible isolators.
11. Experience with equipment validation.
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