LSC have a great contract opportunity for a Stability & Sample Coordinator to join a Cork based Biopharmaceutical company. The site manufactures low volume bulk API for Phase III clinical trials, initial product launch and long term market support. The team on site grow, purify, formulate and bulk fill mammalian cell culture derived APIs for medicines intended for human use.
If you have minimum 3-5 years relevant industry experience and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Contribute to selection of intermediate and product lots produced at the company for stability studies.
o Coordinate and contribute to the scheduling of stability testing in QC.
o Trend stability data and report on same.
o Prepare stability related protocols, summaries, and reports – often for direct submission to pharmaceutical regulatory agencies.
o Coordinate movement and storage of samples for testing within QC, within the company and to and from contract laboratories.
o Manage the retention and reserve sample program.
o Act as technical resource (SME) and train other analysts in areas of expertise.
o Review and approve documents such as standard operating procedures, protocols, reports and track-wise documents.
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, IT, chemical or biological sciences) is required
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!
To apply, submit your CV via this advert or contact Conor Dolan at LSC on 021-4777329 if you have anymore questions about this Stability & Sample Coordinator opportunity!