LSC have a great contract opportunity for an Analytical Technical Steward to join a leading Global Pharmaceutical company based in Cork. The Cork campus has produced small molecule API for over 30 years and has built a new Biotechnology facility which will deliver the next generation of products to the global market.
If you have 5+ years’ experience supporting analytical aspects of monoclonal antibody clinical trial development and/or manufacturing and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Technical review, interpretation, and release of data including release data from CM, stability, process validation, and reference standard characterization
o Utilizes technical skills to lead or perform in-depth investigations into out of specification results and aberrant data. Guides CMs to perform root cause analysis investigations and develop solutions to prevent reoccurrence
o Develop investigational testing protocols and perform testing as required.
o Contribute to annual product review and process validation as required
o Communicate effectively in both written and oral formats within the lab as well as with CMs and business partners
o Participates in internal/external audits as needed
o Coordinate testing needs across sites in support of batch release, stability, process validation, or single batch verification testing
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o Bachelor degree (4 year university) in a science field related to the lab (e.g. Chemistry, Biochemistry, Biology
o Demonstrate proficiency in complex laboratory analysis in a cGMP laboratory, including, but not limited to chromatographic, spectroscopic, and/or microbiological assays.
o Deep understanding of cGMP compliance requirements and regulatory expectations
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 Aaron Kingston at LSC on 021-4777329 if you have anymore questions about this Analytical Technical Steward opportunity!