Analytical Method Development Specialist

2 weeks ago

Dublin, Ireland Cpl Full time

SK biotek Ireland are seeking to recruit an Analytical Method Development Specialist experienced in analytical method development and specifically, chromatographic method development, on a permanent basis.


This position is based at the R&D Centre in Swords, Co Dublin. The R&D Centre has co-located technical and operational expertise, including analytical expertise that supports the development and manufacture of clinical and commercial products (small molecule APIs).

The Analytical Method Development Specialist will be responsible for taking oversight of all analytical method development activities, and to provide technical support for these activities, as well as developing analytical methods to support method introduction for new products. In addition, the successful candidate will provide technical support for all aspects of analytical methodology, method transfer, method qualification and method troubleshooting pertaining to the manufacture of small molecule APIs and intermediates. The successful candidate will also provide support in the day-to-day running and maintenance of the AR&D laboratories. The successful candidate will need to collaborate closely with other functions, including Process R&D, Quality (QA/QC), SHE and external stakeholders/customers working towards the flawless, compliant and right first-time manufacture of existing and new products. In addition, the successful candidate will provide mentorship, where applicable, to more junior analytical staff.


Key responsibilities include:

  • Take oversight of and provide support to all analytical method development activities.
  • Carry out Analytical method development, specifically for HPLC and GC.
  • Perform analytical testing in a timely manner for analytical testing, validation and qualification, where appropriate, to ensure project deadlines are achieved for:
  1. Campaign support
  2. Material release,
  3. Process R&D support (development of in-process control methods, familiarisation experiments),
  4. Reference standard qualification,
  5. Analytical investigations.
  • Prepare and review analytical method development reports.
  • Prepare, review, and execute analytical validation protocols.
  • Prepare and review analytical validation reports.
  • Ensure all documentation is completed to the required standard, right first-time, in compliance with local procedures and in a timely manner.
  • Ensure all instrumentation used is within calibration and is correctly maintained.
  • Liaise with AR&D Senior Analytical Chemists to obtain technical support with instrumentation/analytical methodology and laboratory investigations/quality events or related issues.
  • Ensure training is completed before execution of a task.
  • Attend weekly team meetings and participate in a culture, which is committed to high performance, innovation, and continuous improvement and promotes idea sharing.
  • Meet with manager to discuss performance, provide feedback and identify any development opportunities.
  • Ensure GMP Compliance of laboratory operations and documentation, including testing, write ups, review and approval of protocols, reports and change controls.
  • Ensure a safe work environment for oneself and all employees.
  • Ensure high standards of housekeeping are maintained in the laboratory.


Required Key Skills and Experience include:

  • Ideally a minimum of a BSC/MSc in analytical chemistry or equivalent.
  • Preferably a minimum of 3 to 5 yearsâ experience in analytical activities and analytical method development within a pharmaceutical manufacturing environment.
  • Demonstrable expertise in developing analytical methods, particularly for HPLC and GC.
  • Excellent core competencies such as teamwork, communication skills, and technical writing skills
  • Strong technical background in chemistry, particularly analytical chemistry.
  • Ability to work to tight timelines.
  • Good Troubleshooting skills.
  • Openness to change, receptive to new ideas.
  • Knowledge of FDA and European GMPs requirements, particularly pertaining to laboratory operations.

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