LSC have a great contract opportunity for a QC Product Analyst 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 Comfort with working in a team environment, knowledge of cGMPs and
ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES
- Analytical testing for Drug Substance and Drug Product, release, and stability, including but not limited to the following:
- Analytical testing performed by the lab incl: HPLC, SDS, FTIR, UV, plate-based assays; capillary electrophoresis
- Perform primary review of QC raw data and trend results
- Prepare protocols, summaries, and reports-often for direct submission to pharmaceutical regulatory agencies
- Develop, optimize, validate, and troubleshoot analytical test methods
- Act as technical resource (SME) and train other analysts in areas of expertise
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Customer focus; takes personal responsibility for speed; quality and accuracy of delivery
- Self-motivated and ability to work under pressure
- Team Leadership - active participation team development and continuous improvement including standard work and 5S
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!
Call Alison Jones in LSC on 021 4777 329 to discuss this new role in detail or apply directly via this advert