Technical Team Lead – R&D

Technical Team Lead – R&DMy client, a west of Ireland headquartered, global pharmaceutical manufacturer, seeks to hire a Technical Team Lead to join their R&D team, on a permanent basis, todrive the R&D analytical teams for both the Medical and Veterinary functions. In this role you will report into the Director of R&D in the Medical and Veterinary teams.RESPONSIBILITIES:·Provide technical support to the Medical and Veterinary R&D analytical teams ·Day to day planning of the analytical activities and HPLC allotments·Successful Development of stability indicating methods (Active Assay, Related Substances and/or Preservatives, cleaning method) of the Pipeline products ·Analytical method validations·Resolving analytical queries·Review and approve analytical documents e.g. ECP/STMs/AMT/AMV/PV protocols and any other reports·R&D Support to Registration for responding to technical queries on dossier submissions for new products and licence maintenance.·Responsible for addressing day to day lab issues related to maintenance of machines/calibrations/general maintenance/ implementation of new systems etc.·Review and approval of analytical data generated in the R&D Lab Ensuring the data is correct and no deviations made.·Ensure the logbooks / experiment registers are completed regularly.·Testing of the Laboratory trial samples as per the samples received from the Formulators and provide the results as per the agreed timelines·Characterization of APIs and Reference Products for the proposed Medical and Veterinary Products·Preparation of the Analytical Method Validation protocols and reports·Execution of method validation as per the method validation protocol·Process validation Testing of the Proposed Medical and Veterinary Products·Stability testing of Medical and Veterinary products charged on stability (Lab trials/pilot batches) and associated Reports·Ensure availability of the required standards/columns and reagents to avoid delays in testing.·Update the stability Testing reports periodically and Perform trending on all the stability data·Review and approve the COAs·Review and approve specific reports prepared for the regulatory submission by crossreferring to the raw data.·Maintain the log of Dissolution and HPLC and any other instruments’ calibration and ensure·that the calibrations are performed as per the schedule. If required address the technical issues.·Maintain the R&D lab as per GMP requirements·Report to Manager with any issues and close out points·Any other activity as per the Director of R&D’s instructions·Sound knowledge of analytical method development and validation in line with the ICH and GMP requirements·Hands on experience using HPLC/GC and empower software·Sound knowledge on the cGLP and cGMP requirements·Organizational skills, personal efficiency, time management skills and the ability to prioritize competing demands are key communication skills.·Ability to build relationships and collaborate with others is vital.·Demonstrate and lead on the values, initiatives and culture of an organization. Professional expertise.·Positive and proactive person who is energized by having great responsibility·Practical, action-orientated approach to managing priorities.·Health & Safety requirements (e.g., Manual Handling Training)REQUIREMENTS:·Degree in Science Discipline or equivalent.·At least 10 years’ experience within the pharmaceutical industry in the analytical function·Sound knowledge of empower/GMP/GLP·Strong time management and organizational skills.If interested, please forward your most updated CV to #LI-BF1