LSC have a great contract opportunity for a Scientist to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life.
This role is responsible for the planning, preparation, and management of analytical-related regulatory filings across our diverse portfolio. The ideal candidate will collaborate with cross-functional teams, including analytical development, manufacturing, regulatory, and quality, to ensure the timely and high-quality delivery of filing-related documentation. This position offers the opportunity to contribute to key regulatory submissions, support analytical control strategies, and drive continuous improvement initiatives.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Planning and Coordination of Analytical Filings: Lead the planning, preparation, and management of analytical-related regulatory filings across the portfolio, including support for BLAs, ROW submissions, and PAS filings.
- Regulatory Submission Support: Assist in compiling and reviewing analytical documentation required for regulatory filings, ensuring alignment with project timelines and quality standards.
- Stakeholder Collaboration: Work closely with cross-functional teams, including analytical development, manufacturing, regulatory, and quality, to ensure seamless delivery of high-quality analytical strategies.
- Tracking and Reporting: Maintain clear and accurate tracking of filing-related activities, milestones, and deliverables, providing regular updates to key stakeholders.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- A PhD, MS, or BS in Biological Sciences, Chemistry, or related disciplines with experience within Analytical Strategy & Lifecycle / relevant field, respectively
- Requires working knowledge of the relevant principles and concepts of Analytical Strategy & Lifecycle (JOS / Analytical Procedures / Method Validation etc.) and associated GMP's.
- Understanding and industry hands-on experience with a broad range of assays for testing and characterizing biological products, such as HPLC, iCIEF, gel and capillary electrophoresis, and various spectrometry techniques (e.g., MS, absorption), along with ELISAs.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Cian Marnane on 021 4777 329 if you have any more questions about this opportunity!
