QC Analyst u2013 QC Bioassay

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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 Culture 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 u2013 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. BioMarinu2019s 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 BioMarinu2019s 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 patientsu2019 lives. QC Analyst u2013 Bioassay -Shanbally (Days role)Closing Date 20th February 2023u00A0Excellent opportunity to join a brand new GMP approved Bioassay lab within QC Release at Biomarin.u00A0 This role will be focused on the introduction and continued support of bioassay testing within Quality Control and provide the opportunity to support Biomarinu2019s Enzyme Replacement Therapy modalities for rare genetic disorders.u00A0u00A0 u00A0u00A0QC 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.u00A0 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 bioassay-based analysis; techniques including but not limited to: cell culture, ELISA and plate based assays.u00A0 The dynamic nature of QC Release also provides the opportunity for HPLC/UPLC and viral vector gene therapy testing.u00A0 u00A0u00A0Other responsibilities include: Perform primary review of QC raw data and trend results Prepare protocols, summaries, and reportsu2014often 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 Desirable Skills:u00A0Excellent 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 u2013 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 organisationu00A0Education:MSc in a scientific discipline with 3 years of relevant laboratory experience.u00A0 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.

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