Kilo Lab Specialist

2 weeks ago

Dublin, Dublin City, Ireland Cpl Healthcare Full time

CPL in partnership with our client SK biotek are seeking a GMP Kilo Lab Specialist to join the team for a permanent contract based at Swords.

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 GMP kilo lab specialist on a permanent basis. 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).

Position Description:

You will join a team that identifies, develops, and optimises synthetic routes to APIs, supporting both early and late phase development.

The successful candidate will have a background in Organic Chemistry combined with demonstrated expertise in methodologies utilised to characterise APIs, intermediates, and raw materials.

The successful candidate will have a strong background in GMP manufacturing in a kilo lab environment for clinical stage projects in development working with the team to execute new product introduction (NPI) scaleup at kilo scale.

The GMP kilo lab specialist will be an SME in the development of GMP kilo lab High potency active pharmaceutical ingredients (HPAPI) processes. This will include 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. The role will involve cross-functional collaboration including Operations, Project Management, Quality and SHE groups as well as with our customers.

As part of your role, you will:

  • Work 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, crystallisation isolation, and process safety assessments as required.
  • 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.
  • Collaborate with project engineering and R&D team to build the GMP kilo lab facility and bring new technologies on site.
  • Improve and develop current non-GMP kilo lab offerings.
  • Run Kilo lab scale GMP manufacture in the GMP kilo lab alongside operations and R&D colleagues.
  • Work cross-functionally to ensure that project documentation and campaign readiness activities are completed on time.
  • Work with our customers on development projects to ensure that the final process taken to the manufacturing plant is understood, robust, efficient, in-control and meets their expectations.
  • Actively participate in cross functional manufacturing campaign performance support teams. Lead and support quality and safety investigations as required.
  • 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:

  • 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.
  • Ensuring that GMP, Quality, Health & Safety are considered in all aspects of the role.

Additional skills relevant to the role:

  • Demonstrated capability in the use of standard tools for root cause analysis and standard statistical tools.
  • Experience in chromatography, nanofiltration, Freeze drying, or Tangential flow filtration would be beneficial.
  • Experience with Gloveboxes and/or flexible isolators.
  • Experience with High potent APIs.
  • Experience with equipment validation.
  • Graduate training in organic chemistry or chemical engineering.

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.
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