JO-2412-545426
Our client, API manufacturing facility in Dublin, requires an API Organic Chemist to join their team, supporting projects from early clinical phases through to commercial production. The successful candidate will be an Subject Matter Expert in the development of GMP kilo lab High potency active pharmaceutical ingredients (HPAPI) processes. This will include New Product Introductions from customer, process development, process safety, process monitoring and troubleshooting of manufacturing in the GMP kilo lab facility, scale up and transfer to manufacturing plant for commercial scale.
Role
• Work 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, crystallisation isolation, and process safety assessments as required.
• Create all required GMP paperwork including Master Batch records for kilo scale materials.
• Collaborate with R&D chemists to ensure that process development operations demonstrated in the laboratory can be implemented successfully in the kilo lab.
• Ensure that the equipment is qualified and ready for batch manufacture.
• Collaborate with project engineering and R&D team to build the GMP kilo lab facility and bring new technologies on site.
• Improve and develop current non-GMP kilo lab offerings.
• Run Kilo lab scale GMP manufacture in the GMP kilo lab alongside operations and R&D colleagues.
• Work cross-functionally to ensure that project documentation and campaign readiness activities are completed on time.
• Work with our customers on development projects to ensure that the final process taken to the manufacturing plant is understood, robust, efficient, in-control and meets their expectations.
• Actively participate in cross functional manufacturing campaign performance support teams. Lead and support quality and safety investigations as required.
• Additionally, you will take an active role in the delivery of R&D metrics for safety and quality across all processes and activities operating on site.
Requirements:
• Degree in chemistry or chemical engineering with min 5 years experience in a GMP kilo lab or pilot plant in the pharmaceutical industry.
• Regulatory understanding of GMP requirements for the manufacture of clinical stage projects
• Use of glass reactors at kilo lab scale
• Strong interpersonal and communicational skills and demonstrated ability to work across a matrix environment.
• Excellent problem-solving skills and commitment to continuous improvement.
• Ensuring that GMP, Quality, Health & Safety are considered in all aspects of the role.
• Demonstrated capability in the use of standard tools for root cause analysis and standard statistical tools.
• Experience in chromatography, nanofiltration, Freeze drying, or Tangential flow filtration would be beneficial.
• Experience with Gloveboxes and/or flexible isolators
• Experience with High potent APIs
• Experience with equipment validation
