About the Role
We are seeking a highly skilled GMP Kilo Lab Specialist to join our team at SK biotek Ireland, an SK pharmteco company. The successful candidate will have a background in Organic Chemistry and experience in methodologies utilised to characterise APIs, intermediates, and raw materials.
Responsibilities:
* Work with a team of R&D chemists to scale up development projects in the laboratory, including development, completion of proof-of-concept studies in the kilo lab, crystallisation isolation, and process safety assessments.
* 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.
* Cross-functionally collaborate with Operations, Project Management, Quality and SHE groups as well as with customers to execute New Product Introduction (NPI) 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.
Requirements:
* Degree in chemistry or chemical engineering and experience in a GMP kilo lab or pilot plant in the pharmaceutical industry of 5 years or more.
* 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.
About Us:
SK biotek Ireland is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France, and Ireland. We are part of the wider SK Inc. with revenues of $88 billion in 2022. Our mission is to 'make what matters for a healthy, happier world,' from grams to tonnes.