Principal Analytical Team Lead (R&D Vet & Med)
About Chanelle Pharma:
Chanelle Pharma is Ireland’s largest indigenous generic pharmaceutical manufacturer of both medical and veterinary products.
Serving customers in 96 countries worldwide, Chanelle Pharma is a partner of choice in the development and manufacturing of pharmaceutical products to the world’s leading human generic and animal health multinationals and distributors. We are passionate about understanding and addressing the challenges facing our medical and veterinary customers and bringing them innovative and effective products and solutions.
This is an opportunity to lead a dynamic function within the R&D team. We are looking for an individual who will drive the R&D analytical teams in both the Medical and Veterinary functions and fulfil Chanelle Pharma’s vision to be the most valued global provider of high quality, competitively priced pharmaceutical products and to provide excellent services and support to our customers.
In this role you will report into the Head of R&D in the Medical and Veterinary teams.
Provide technical support and supervision to the Medical and Veterinary R&D analytical teams to cover the disciplines including:
- 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 the analytical queries.
- Review and approve analytical documents e.g. ECP/STMs/AMT/AMV/PV protocols and any other reports.
- Support to Registration for responding to technical queries for analytical issues.
- Responsible for addressing day to day lab issues related to maintenance of machines/calibrations/general maintenance/ implementation of new systems etc.
- Ensure monthly four hours training is achieved.
- Ensure the log books/experiment registers are completed regularly.
- Testing of the Laboratory trial samples as per the samples received from F&D and provide the results as per the agreed timelines.
- Characterisation 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).
- Stability Reports Preparation.
- Ensure availability of the required standards/columns and reagents to avoid delays in testing.
- Update the stability Testing reports periodically.
- Review and approval of analytical data generated in the R&D Lab. Ensure the data is correct and no deviations made.
- Perform trending on all the stability data.
- Review and approve the COAs.
- Review and approve specific reports prepared for the regulatory submission by cross-referring 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.
- Record number of OOS for the department and report on a monthly basis.
- Report to Manager with any issues and close out points.
- Co-ordinate new molecule assessments with the Molecule Assessment Team.
- Responsible R&D Lead for analytical area in inspections and audits, internal and external.
- Any other activity as per the Head of R&D’s instructions.
- Sound knowledge of analytical method development and validation in line with the ICH and GMP 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 organisational skills.
- Health & Safety requirements.
- Manual Handling Training.
Office & Laboratory Duties.