R&D Specialists, GMP Kilo Lab, Preparative Chromatography, HPAPI New

1 day ago


Dublin, Ireland CPL Full time

Cpl, in partnership with SK biotek Ireland, is seeking R&D Specialists to join their growing team in Swords, Co. Dublin.

SK biotek Ireland, an SK pharmteco company, 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.

For nearly 60 years, their 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. With a talented workforce, exceptional technical capabilities, and world-class facilities, the company has played a key role in manufacturing some of the world’s most important medicines.

Find out more about their work: https://vimeo.com/skpharmteco

About the Roles

SK biotek Ireland is hiring for multiple specialist positions in their brand-new R&D plant at Swords, Dublin.

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, SHE (Safety, Health & Environment), and Project Management teams to ensure compliance with GMP regulations and industry best practices.

You’ll be part of a dynamic and solution-driven team, working on complex challenges, optimising processes, and maintaining the highest standards in pharmaceutical manufacturing.

Available Roles & Key Responsibilities

GMP Kilo Lab Specialist

· Develop and optimise synthetic routes for APIs.

· Scale up chemical processes from laboratory to kilo-scale GMP manufacturing.

· Execute New Product Introductions (NPI), process safety evaluations, and troubleshooting.

· Ensure equipment qualification and batch manufacturing readiness.

· Support technology transfer from R&D to full-scale commercial production.

Preparative Chromatography Specialist

· Develop and implement purification strategies for APIs, including HPLC, flash chromatography, and chiral separations.

· Optimise and scale up purification processes from mg to kg level.

· Perform impurity isolation and process optimisation.

· Collaborate with GMP kilo lab and manufacturing teams for seamless process integration.

HPAPI Specialist

· Lead the safe handling, containment, and development of Highly Potent APIs (HPAPIs).

· Work with gloveboxes, flexible isolators, and containment technologies.

· Support process development, safety evaluations, and regulatory compliance.

· Scale up complex HPAPI processes, including Antibody Drug Conjugate (ADC) linker payloads.

· 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, SHE, 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.

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