LSC have a great contract opportunity for MSAT Scientist / Engineer 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 bachelor's degree in Biochemistry, Biotechnology, Bio- processing, or Chemical Engineering, or similar, with 3-5 years of relevant experience in Process Development, Manufacturing, or Sciences and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Act as Subject Matter Expert (SME) for product and process knowledge, be highly knowledgeable of product and process trends by providing input to APQR for analysis and for driving process technology innovations.
- Technical understanding in cell culture and/or protein purification science and technology
- Collect data for ongoing process verification, tracking and evaluation of product performance and implementation of CAPAs.
- Interpret complex technical challenges and provide resolutions to enable decisions.
- Perform first line evaluation of product and process related issues (deviations, complaints, OOS, OOE).
- Lead and provide constructive challenge during process investigations and steer investigations to be data driven, risk-based and comprehensive.
- Support Process Steward for assessment of technical changes, establishment of root-cause analysis, Quality Risk Assessment, process control strategy.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Masters or PhD qualification in a relevant technical area would be an advantage.
- Experience working within a regulated or pharmaceutical environment would be desirable.
- An interest in Advanced Data Analytics and Design of Experiments with experience in RStudio, SAS, JMP etc would be desirable.
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 Peter Cronin at LSC on 021-471 8208 if you have any more questions about this opportunity!
