Preparative Chromatography Specialist (SME)
Permanent
Location: Swords Dublin, Ireland
ABOUT US?
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 a preparative chromatography specialist on a permanent basis. This position is based at the R&D Department in Swords, Co Dublin. This position is based at the R&D Department in Swords, Co Dublin. The R&D Department has co-located technical and operational expertise, including analytical expertise that supports the development and manufacture of clinical and commercial products (small molecule APIs) including highly potent APIs with OELs less than 1ug. /m3 and lower.
Position Description:
The successful candidate will use their experience in preparative chromatography to guide development of appropriate purification methods for small molecules from the mg to kg scale for new product Introductions (NPI)s including highly potent APIs and intermediates. This will include technology transfer from customer, process development, process safety, process monitoring and troubleshooting of preparative chromatography in the laboratory, as well as scale up and manufacturing in the GMP kilo lab facility. The role will involve cross-functional collaboration including with our Operations, Quality and SHE groups as well as with our customers. The R&D department at SK biotek Ireland are a customer focused group supporting projects from early clinical phases all the way through to commercial production. As part of your role in these activities, you will:
• Collaborate with a team of R&D chemists to scale up development projects in the laboratory. This may include development, completion of proof-of-concept studies in the kilo lab, isolation, and process safety assessments as required.
• Perform analytical and preparative purifications of research materials to support process development.
• Execute achiral and chiral purification of pharmaceutical compounds and isolation of impurities.
• Evaluate and develop separation conditions through solubility, loading, and stability studies at mg to g scale.
• Conducts scaleup demonstrations of separations at multi g scale.
• Execute early deliveries of 100’s g to kg scale in conjunction with our process R&D team.
• Maintain lab presence and be actively involved in lab work.
• Analyze and interpret scientific results.
o Author scientific reports and present work as needed.
• Initiate and champion new technology’s introduction.
o Ensure that the chromatography equipment is qualified and ready for batch manufacture.
o Build and maintain contacts with representatives of equipment and material suppliers.
o Initiate and foster collaboration with external research institutes, companies, and universities.
o Keep up-to-date knowledge on purification related technologies.
o Represent department in cross-functional working groups.
• Conduct your work within the predefined safety, environmental and quality standards.
• Create Master Batch records for Chromatography.
• Collaborate with R&D chemists to ensure that process development operations demonstrated in the laboratory can be implemented successfully in the GMP kilo plant.
• Collaborate with project engineering and R&D team to build the capabilities within GMP kilo lab facility and bring new technology on site.
• Improve and develop current chromatography offerings.
• Run Kilo lab scale GMP manufacture in our GMP kilo lab alongside operations and R&D colleagues.
• Collaborate with R&D project leads, project management group, and other functions such as SHE, Operations and Quality to ensure that project milestones are delivered as per the project plan.
• Collaborate with our customers in development projects to ensure that the final process taken to the manufacturing plant is understood, robust, efficient, in-control and meets their expectations.
• Additionally, you will take an active role in the delivery of R&D metrics for safety and quality across all processes and activities operating on site.
Minimum Requirements:
Required Key Skills and Experience include:
• Strong technical background in preparative chromatography in lab and pilot lab scale in Industry of 5 years.
• PhD or Master’s degree with specialization in chemistry/ engineering or related discipline.
• In depth knowledge and technical proficiency in preparative chromatography, HPLC and related techniques.
• Experience with chemical process development, scale-up and GMP manufacturing with emphasis on chromatographic purification.
• Experience in both low pressure (flash) as well as high pressure (prep) chromatography
• Proven problem-solving capacity.
Additional skills relevant to the role:
• You are practical and results driven.
• You are efficient, flexible, and dynamic.
• You integrate and work effectively in a multidisciplinary team.
• You have good social and communication skills.
• You ensure that GMP, Quality, Health & Safety are considered in all aspects of the role.
• Experience in troubleshooting and Clinical batch manufacture in a GMP environment.
• Demonstrated capability in the use of standard tools for root cause analysis and standard statistical tools.
• Experience in Freeze drying or Tangential flow filtration.
• Use of glass reactors at kilo lab scale or experience in integration of chromatography into an API plant
• Experience with Gloveboxes and/or flexible isolators
• Experience with equipment validation
Level of role commensurate with candidate experience
Why choose a career at SK biotek?
A career with purpose and a chance to work with a world-leader in contract development and manufacturing in a fast-paced, dynamic, and growing organisation. Here at SK biotek Ireland, we believe we enhance patients’ lives, and we need you! It reminds each one of us that what we do matters, and our mission is to ‘make what matters for a healthy, happier world’ – whatever your title, whatever your role, you act as a catalyst in a chain of events that helps millions of people all over the globe. By choosing a career with SK biotek Ireland, you will join a team of passionate people working together to improve lives by making what matters for a healthy, happier world.
Other Benefits include:
• Excellent opportunities for career enhancement and personal development.
• Competitive base salary.
• Annual bonus linked to business results.
• A well-established further education program.
• Pension scheme.
• Private Healthcare.