Sr Associate QC (BioAnalytical Sciences) is required for a South Dublin based Biopharmaceutical company that specialises in secondary manufacturing activities such as Formulation, Fill Finish and Packaging. In July 2015 the site opened a $300million investment, which added significantly to the sites laboratory, filling, packaging and distribution (including cold chain) capabilities. The site is a fast paced, collaborative, team based working environment, where you get an opportunity to work with other highly skilled staff in a strategically important site in the companies global supply chain.
The Sr Associate QC Bio will:
o Experience in a wide variety of analytical techniques including but not limited to Bioassays, Immunoassays, Cell Culture and Aseptic Technique. Experience with liquid-handling robots is also preferable.
o Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
o Participate in the peer review of analytical data.
o Responsible for providing technical guidance and applying expertise and critical thinking to help to resolve technical issues.
o Lead training of staff on technical aspects of job as required.
o Develop, revise and implement procedures that comply with appropriate regulatory requirements.
o Qualification of analytical equipment and related testing functions.
o Participate in Analytical Method Transfers
o Compliance with Standard Operating Procedures and Registered specifications.
The Sr Associate QC Bio will require:
o Hold a third level qualification (Degree) in Biology, Biotechnology or related discipline.
o Have 4-5 years of experience in a pharmaceutical/healthcare Laboratory.
o Strong background in Bioassays, Immunoassays and Cell Culture is essential.
o Experience with TrackWise, Change Control Systems, EDMQ and SAP an advantage
Call Amparo in LSC on 0214777 329 to discuss this Sr Associate QC Bio role in more detail or apply directly via this advert.