QC Analyst – QC Analytical
Who We Are
For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.
And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.
Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.
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. Come join our team and make a meaningful impact on patients’ lives.
QC Analyst – Analytical - Shanbally (days role)
Closing date 20th February 2023
Exciting opening in a 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 excellent opportunity 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
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
MSc in a scientific discipline with 3+ years of relevant laboratory experience.
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.