We are seeking an API Organic Chemist to join our team at an API manufacturing facility in Dublin. The successful candidate will be a Subject Matter Expert in the development of GMP kilo lab High Potency Active Pharmaceutical Ingredients (HPAPI) processes.
Key Responsibilities
* Work 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, crystallization 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 the 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 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.
* 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 a minimum of 5 years of 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.
* Experience in the use of glass reactors at kilo lab scale.
* Strong interpersonal and communication skills with a 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.