QCAT Analyst / QCAT Associate ScientistLocation Cork, Ireland Apply
Who We Are
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
The QC Analytical Technology (QCAT) Analyst/Associate Scientist is responsible for laboratory work in support of studies throughout the lifecycles of pharmaceutical drug substances and drug products in a cGMP environment. They are responsible for providing support to activities related to analytical method development, assisting with troubleshooting work, executing validation and transfer protocols, supporting the writing, and reviewing of protocols and reports, supporting training to site QC, Contract Test Labs, and In Country Testing Labs in new techniques and methods and when necessary, assist in the preparation of regulatory submission documents.When required, the analyst/associate scientist also assists in the on-time release and stability testing of pharmaceutical drug substances and drug product.
This position reports to the QCAT Technical Lab Operations Manager.
•Analytical testing performed by the lab incl: HPLC/UPLC, UV Spectrophotometry, plate based assays including ELISAs and cell based Bioassays, capillary electrophoresis, qPCR, etc
•Provide technical expertise for analytical methods in QC, support the maintenance of method and analytical equipment performance
•Perform primary review of QC raw data and trend results. Evaluate results against defined acceptance criteria
•Prepare protocols, summaries, and reports—often for direct submission to pharmaceutical regulatory agencies
•Develop, optimize, validate and troubleshoot analytical test methods
•Draft QC SOPs
•Act as technical resource (SME) and train other analysts in areas of expertise
•Conduct, support and document laboratory investigations to rapidly identify the root cause and to establish effective corrective action(s) with minimal delay
•Interpret and apply 21CFR, USP, EP, JP and ICH regulatory guidelines and directives
•Maintain the laboratory in an inspection-ready state
•Interact directly with regulatory agency inspectors during audit
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.