SK biotek Ireland, an SK pharmteco company, 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. The Swords Campus has led the way in the development, scale-up and commercial manufacture of Active Pharmaceutical Ingredients (APIs), Highly Potent Active Pharmaceutical Ingredients and Chemical Intermediates for almost 60 years. With a talented workforce, exceptional technical capabilities, and facilities we have made some of the world’s most important medicines and continue to do so. Further information on SK pharmteco can be found at https://vimeo.com/skpharmteco.
Current Need:
SK biotek Ireland are seeking to recruit an PR&D Chemist on a temporary basis, on a 12 month contract. This position is based at the R&D Centre in Swords, Co Dublin. The R&D Centre has co-located technical and operational expertise, including analytical expertise that supports the development and manufacture of clinical and commercial products (small molecule APIs).
Position Description:
The PR&D Chemist will have experience in synthetic organic chemistry. They will be responsible for providing support for all aspects of new and existing chemical processes development, technology transfer, process scale-up, process safety, process monitoring, and process troubleshooting for small molecules. The role will involve cross functional collaboration with other functions including Operations, Quality, SHE and external stakeholders working towards existing and new product introduction and ensuring all processes are understood, robust, efficient and in control
• Lead development projects in the laboratory, including route scouting and route development, proof of concept, crystallisation optimisation, and process safety assessment.
• Provide technical support to the manufacture of APIs and intermediates manufactured at SK biotek Ireland, with a focus on optimisation and investigation support.
• Identify and implement projects to optimise processes, considering scale-up and manufacturing aspects and Critical to Quality Attributes.
• Leverage data monitoring and PAT tools in the laboratory such as FBRM, Raman, IR, as required. Identify and implement new technologies to support development for the business needs of the site.
• Collaborate with R&D analytical chemists and Operations engineers on new products introduction and scale up activities, including process development in the laboratory, customer engagement, troubleshooting, documentation, and campaign readiness.
• Support chemistry assessments for new products as required.
• Lead optimisation projects on throughput and yield in collaboration with Operations engineers.
• Support continuous process verification through collection and trending of data for commercial products, identifying Out of Trends (OOT) and Statistical Alert Events (SAE) and leading investigations where required with support from engineers and analytical chemists as required.
• Actively participate in manufacturing campaign performance support teams.
• Lead and support quality and safety investigations.
• Ensure that GMP, Quality, Health & Safety are considered in all aspects of the role.
Minimum Requirements:
Required Key Skills and Experience include:
• Strong technical background in chemistry.
• PhD in organic chemistry or equivalent industrial experience in process development.
• Strong interpersonal and communicational skills and demonstrated ability to work across a matrix.
• Excellent problem-solving skills and commitment to continuous improvement.
• Experience in project management, troubleshooting and continuous process verification.
• Demonstrated capability in the use of standard tools for root cause analysis and standard statistical tools.
• Demonstrated capability in the use of various analytical/diagnostic tools including PAT, chromatography and process safety.