Our client, a major multinational pharmaceutical company in Westport, Co. Mayo, is seeking to recruit a Senior Scientist to join their team on a 12-month contract.
Responsibilities:
1. Lead the development and testing of lab methods (mainly HPLC and ELISA) for new products, making sure everything is done to high quality and meets regulations.
2. Manage the handover of these lab methods from the research team to the manufacturing team, making the process as smooth as possible.
3. Plan and track projects related to testing methods to make sure all deadlines and goals are met.
4. Ensure all testing methods follow strict industry and safety rules.
5. Work closely with teams in research, quality, manufacturing, and regulatory areas to solve problems and improve processes.
6. Spot potential technical issues early and fix them before they become bigger problems.
7. Write, review, and maintain important lab documents, including instructions, reports, and procedures.
8. Train and guide junior staff on how to develop and use testing methods properly; help with training the quality control team when methods are handed over.
9. Keep up to date with new technologies and trends and bring useful innovations into the work.
10. Clearly communicate progress and key updates to everyone involved in the project.
Requirements:
11.. in a relevant science subject with a minimum of 10 years' experience / or a. with at least 8 years / or a PhD with at least 3 years' relevant industry experience.
12. Preferred experience in analytical method development, transfer, and validation.
13. Proficiency with chromatographic (., HPLC) and bioassay (., ELISA) techniques.
14. In-depth knowledge of GMP, ICH guidelines, and regulatory standards for analytical methods.
15. Understanding of the drug development process and regulatory submissions (., IND, NDA).