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Senior MS&T Chemist

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Dublin
  • Sector: Quality & Compliance
  • Date posted: 31/01/2018
  • Job reference: J379498A

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SK biotek Ireland are seeking to recruit a Senior Manufacturing Science and Technology Chemist, on a permanent basis.

This position is based at the API Centre of Excellence in Swords, Co Dublin. The centre of excellence has co-located technical and operational expertise, including analytical and engineering expertise that supports the launch and commercial manufacturing of a technology or value chain step (Drug substance).

The Senior Manufacturing Science and Technology Chemist will be responsible for providing strong scientific leadership for all aspects of new and existing chemical processes development, technology transfer, process scale-up, process monitoring, and process troubleshooting for small molecules. Other responsibilities will include cross-functional team leadership and/or membership, authoring technical reports and supporting CMC aspects of regulatory dossiers. The role will involve significant cross functional collaboration with other functions including R&D, manufacturing, Quality, EHS and external stakeholders working towards existing and new product introduction and ensuring all processes are understood, robust, efficient and in control.

Key Responsibilities Include

  • Provision of technical support on the design and improvement of process chemistry routes of synthesis (including synthetic route scouting and development of second generation processes).
  • Provision of technical support to the manufacture of APIs and Intermediates manufactured at Swords. Serve as subject matter expert (SME) on the site's products, representing the site to external stakeholders.
  • Collaboration with external stakeholders to support the development and the technology transfer of new drug candidates to commercial sites. Act as a key team member in the transfer for a new drug substance throughout the tech transfer lifecycle from planning, process performance and regulatory support.
  • Engage with internal and external stakeholder (including Drug Product customers as required) to support end to end product management.
  • Driving process robustness performance through process capability analysis and assessment. Use of this information and knowledge to contribute to comprehensive process verification reports and identifying and executing process robustness improvement projects, where required.
  • Providing technical leadership in the understanding of root causes for out of trend or out of specification results or deviations through application of standard tools.
  • Application of Lean tools and techniques to improve processing efficiency such as throughputs and yields.
  • Maintain focus on industry and technology trends and opportunities. Champion new technology for process understanding/monitoring. Maintain/develop links with external networks including Universities & Industry groups.
  • Provide coaching, technical oversight and support for the activities of other chemist with the department. Support the development of other chemists on-site.

Required Key Skills And Experience Include

  • PhD in Synthetic Organic Chemistry.
  • 5+ years of experience in the Pharmaceutical business.
  • Highly flexible, works well in a team environment, and has necessary skills to organize, mobilize, communicate, influence and lead.
  • Excellent critical thinking and problem solving abilities. Must be capable of grasping complex technical issues and making sound decisions based on the fundamental principles of the technology, the data, and applicable business and strategic issues.
  • Subject matter expertise in chemical synthetic route development.
  • Subject matter expertise in crystallization process development and demonstrated capability in the use of various analytical/diagnostic tools including PAT .
  • Experience of CMC regulatory requirements for pharmaceutical products and the evolving opportunities offered by application of QbD principles.
  • Experience in defending processes, procedures and investigations during FDA/EMA/HA inspections is desirable.
  • Understanding of statistical process analysis and control methods. Experience in using statistical software packages is desirable.
  • Demonstrated capability in the use of various analytical/diagnostic process safety tools (thermal stability, reaction kinetics and gas evolution, decomposition) is desirable.
  • Good understanding of 21CFR/cGMP documentation, electronic systems and EHS requirements.
  • Ensure that GMP, Quality, Health & Safety are considered in all aspects of the role.

For more information please contact Darragh on