NPI Analytical Manager

 NPI Analytical Manager – Team Horizon
 
Team Horizon has an exciting opening for a NPI Analytical Manager to join our client’s leadership team in their Manorhamilton Road site in Sligo.
The NPI Analytical Manager is 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 characterisation of unknown materials.
 
Why you should apply:

• Join a company that has developed a stand-out culture of innovation, inclusion, and development, and consistently features as a great place to work.


• Generous package with good base salary and benefits to including but not limited to health insurance, pension, and bonus.


• Join an organisation who uses Innovative new technologies, who embrace diversity, equality and inclusion and puts patients first.

 
What you will bedoing:

• 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.

 
What you need to apply:

• 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.