QC Analyst (TEMPORARY)
Location Cork, Ireland ApplyWho We Are
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Technical Operations
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 – Analytical - Days Role
12 Month Temporary Contract
Excitingopening ina newly 5S certified Analytical lab within QC Release at BioMarin. This role will be focused on the ongoing support of BioMarin's Enzyme Replacement Therapy products for release and stability. It also provides an excellentopportunity to be involved in Process Performance Qualifications (PPQs) as part of the rapidly expanding Shanbally site including the new fill finish facility and packaging operations.
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 of HPLC/UPLC in addition to plate-based assays as required by the team. The dynamic nature of the team also provides the opportunity for bioassay and/or viral gene therapy testing.
Other responsibilities include:
- Perform primary review of QC raw data and trend results
- 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
Desirable Skills:
- 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:
- MSc in a scientific discipline with 1+ years of relevant laboratory experience.
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
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.