QC Analytical Manager is required for 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. The site is currently moving from commissioning into full scale commercial operations. This is an opportunity to work in a company that is innovative (ranked 10th most innovative by Forbes) and recognized globally as one of the fastest companies to get medicines to market.
This role offers you a chance to work in a state of the art facility, in an innovative Biotechnology company, with excellent career development opportunities and a clear and committed patient focus.
The QC Analytical Manager will:
o Lead the laboratory personnel responsible for testing and disposition of drug substance and drug product.
o Develop and lead the QC team in areas of expertise, use of operational excellence tools, and high performance team behaviours.
o Provide technical expertise and leadership to the QC group ensuring samples are tested under cGMP within specified timelines.
o Provide oversight of out-of-specification/out-of-trend result investigations and documentation of same.
o Interface with other BioMarin departments (Regulatory Affairs, Manufacturing, Quality Assurance, Facilities, etc.) and contractors as necessary.
o Maintain the laboratory in an inspection-ready state.
o Interpret and apply applicable 21CFR, USP, EP. JP, and ICH regulatory guidelines and directives
The QC Analytical Manager will require:
o M.Sc. with at least 8 years of experience in a relevant functional area, or a B.Sc. with at least 10 years experience in a relevant functional area (at least 2 years in Quality Control).
o 8+ years experience in a cGMP regulated Quality Control environment.
o Demonstrated expertise with analytical methods used to assess pharmaceuticals and biologics, especially HPLC and other analytical tools
o Organizational and management skills to coordinate multi-discipline project groups
o Manage a team of approx 12 people
Call Mairead in LSC on 0214777 329 to discuss this QC Analytical Manager role in more detail or apply directly via this advert