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NPI Analytical Manager

  • Sector: Science & Pharma
  • Contact Email: davin.ferguson@collinsmcnicholas.ie
  • Job Ref: 17957

NPI Analytical Manager

Are you interested in joining a company where you can unleash your full potential?

We are now recruiting an NPI Analytical Manager to be part of the leadership team at a busy pharmaceutical plant in Sligo. Reporting directly to the Technical Operations Manager, you will be responsible for leading the Technical Operations NPI analytical team that supports API and OSD programs while providing technical support to the QC department during investigations and for characterization of unknown materials. 


What will your role entail?

  • 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.


So, what education and experience do you need to be this leader?

  • You will have a BSc in science or equivalent (Chemistry or Analytical Chemistry preferred) with 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.


Our client is an Equal Employment Opportunity Employer who values bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment.

Competitive remuneration package on offer to the successful candidate. 

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For a confidential discussion and more information on the role, please contact Davin Ferguson.

davin.ferguson@collinsmcnicholas.ie

071 9140251