Join SK biotek Ireland's Dynamic Team as an R&D Specialist
SK biotek Ireland, a global Contract Development and Manufacturing Organization (CDMO), is seeking talented R&D Specialists to contribute to their innovative team in Swords, Co. Dublin.
With state-of-the-art facilities in Korea, the US, France, and Ireland, SK biotek Ireland is part of the wider SK Inc., which had revenues of $88 billion in 2022.
The company's Swords Campus has been a leader in the development, scale-up, and commercial manufacture of Active Pharmaceutical Ingredients (APIs), Highly Potent APIs (HPAPIs), and Chemical Intermediates for nearly 60 years.
About the Roles
As an R&D Specialist, you will play a key role in developing, scaling up, and manufacturing pharmaceutical compounds using cutting-edge technologies.
You will collaborate cross-functionally with Operations, Quality, Safety, Health & Environment, and Project Management teams to ensure compliance with GMP regulations and industry best practices.
Key Responsibilities:
* GMP Kilo Lab Specialist:
o Develop and optimise synthetic routes for APIs.
o Scale up chemical processes from laboratory to kilo-scale GMP manufacturing.
o Execute New Product Introductions (NPI), process safety evaluations, and troubleshooting.
o Ensure equipment qualification and batch manufacturing readiness.
o Support technology transfer from R&D to full-scale commercial production.
* Preparative Chromatography Specialist:
o Develop and implement purification strategies for APIs, including HPLC, flash chromatography, and chiral separations.
o Optimise and scale up purification processes from mg to kg level.
o Perform impurity isolation and process optimisation.
o Collaborate with GMP kilo lab and manufacturing teams for seamless process integration.
* HPAPI Specialist:
o Lead the safe handling, containment, and development of Highly Potent APIs (HPAPIs).
o Work with gloveboxes, flexible isolators, and containment technologies.
o Support process development, safety evaluations, and regulatory compliance.
o Scale up complex HPAPI processes, including Antibody Drug Conjugate (ADC) linker payloads.
o Participate in HPAPI audits, risk assessments, and industry benchmarking.
Requirements:
* Degree in Chemistry, Chemical Engineering, or a related field (Master's or PhD preferred).
* 5+ years of experience in GMP kilo lab, process development, or purification.
* Strong knowledge of GMP manufacturing, process safety, and analytical techniques.
* Ability to collaborate cross-functionally with Operations, Quality, Safety, Health & Environment, and Project Management teams.
* Excellent problem-solving skills, adaptability, and attention to detail.
* Experience with API synthesis, kilo-scale reactors, crystallisation, and GMP manufacturing is required.
* Expertise in HPLC, flash chromatography, chiral separations, and impurity isolation is essential.
* Experience with HPAPI containment technologies, gloveboxes, isolators, and process safety evaluations is required.
About SK biotek Ireland
SK biotek Ireland is a global Contract Development and Manufacturing Organization (CDMO) with state-of-the-art facilities in Korea, the US, France, and Ireland.
They are part of the wider SK Inc., which had revenues of $88 billion in 2022.