NPI Analytical Manager
Job ID: JOB-12060
NPI Analytical Manager
My client who is a leading pharmaceutical company is looking for an NPI Analytical Manager to join their team on their Sligo site on a permanent basis.
- Be responsible for the management and oversight of the NPI Analytical team to include: hiring, setting performance expectations, providing performance feedback, development of staff and handling of personnel issues
- Enhance safety culture on site and ensure all new methods, materials and technologies are appropriately safety assessed.
- Lead a culture of strong compliance with cGMP and GLP principles while demonstrating leadership in applying logical deductive reasoning during analytical investigations.
- Ownership of the NPI analytical method transfer process on site.
- Update and optimize this business process as required and support investigations and develop robust CAPAs.
- Support the rapid identification and characterization of unknown species during investigations.
- Analyse analytical data to support decision making and employ operational excellence principles during analytical method development.
- Employ KPI measures to measure and improve performance within the team.
- Ensure analytical testing is completed on schedule for both API and OSD clinical trial batches and support R&D (Research & Development) and S&T (Science & Technology) in the development of analytical specifications.
- Identify and introduce new technology as required by NPI projects.
- Transfer analytical methods and knowledge to QC analysts.
- Ensure the site is audit ready. Support surveillance and PAI inspections as required.
- Support divisional initiatives/CoEs as required.
- Ensure NPI analytical team maintains complete and precise records, aligned with data integrity principles, of all tests performed.
- You will have a BSc in science or equivalent (Chemistry or Analytical Chemistry preferred)
- 2-5 years of laboratory and supervisory experience.
- Broad understanding of a wide range of analytical techniques including, chromatography, spectroscopy, wet chemistry and solid-state characterization techniques (inc. PXRD, PSD, BET analysis).
- Expertise in understanding the application of the appropriate analytical techniques.
- Solid grounding in chemistry principles and theory to support sound technical decision making.
- Experience in analytical software control systems (e.g. Empower).
- Knowledgeable in the application of statistics.
- Experienced in navigating current regulatory requirements and compendial requirements, in particular USP and EP.
- Program management skills.
For further information on this role in Sligo please contact Emma Griffin on 086 0334325/ firstname.lastname@example.org Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/ Please Note:
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