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.
QC Analyst - Viral Vector - Shanbally, Ringaskiddy, Cork
Onsite Role - Days
Closing Date 30 Jan 2024
Opportunity to join a newly expanded, GMP Viral Vector laboratory within Quality Control – Release, at Biomarin, runner up in the Irish Laboratory of the Year Awards for Start-up lab and Pharmaceutical Lab.This exciting role will be focused on the testing and lot release of viral gene therapy products for clinical and commercial use with opportunities to also support Biomarin’s Enzyme Replacement Therapy modalities for rare genetic disorders.
QC Release are a high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. QC Release operates to an extremely high standard of quality and compliance.
A high level of initiative, energy and motivation are key role requirements, as well as organizational skills.
Reporting to the QC Team Lead, the primary role of the QC Analyst is to provide support to internal and external customers by providing quality testing and delivering results in accordance with GMP standards.
The role primarily covers testing for gene therapy-based Drug Product, release and stability; techniques including, but not limited to, qPCR/ddPCR, cell culture, ELISA, liquid chromatography and other plate-based assays.The dynamic nature of QC Release also provides the opportunity for HPLC/UPLC testing.
Other responsibilities include:
Perform primary review of QC raw data and trend results
Prepare protocols, summaries, and reports—often for direct submission to pharmaceutical regulatory agencies
Draft/Update QC SOPs
Act as technical resource (SME)and train other analysts in areas of expertise
Evaluate results against defined acceptance criteria
Conduct and document laboratory investigations to completion
Maintain the laboratory in an inspection-ready state
Interact directly with regulatory agency inspectors during audits
Interface with other BioMarin departments (Manufacturing, Quality Assurance, Facilities, etc.) and contractors as necessary
Excellent communication skills both written and verbal
Customer focus; takes personal responsibility for speed; quality and accuracy of delivery
Self-motivated and ability to work under pressure
Team Leadership – active participation team development and continuous improvement including standard work and 5S
Successful track record in achieving goals as part of a team within a growing, dynamic environment
Demonstrated adaptability and flexibility to support a growing organisation
Education and experience
- MSc in a scientific discipline
- Minimum of with 3+ years of relevant laboratory experience in a GMP environment
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.