QCAT Specialist - Ireland (also open in US)Location Cork, Ireland Apply
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 hat 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.
QCAT Specialist - Shanbally, Ringaskiddy, Cork
Specialist – Global Stability Program Management
The Global Stability Program Management Specialist is responsible for supporting the development and oversight of stability programs to ensure product quality and compliance with regulations and guidances. This includes stability program development, facilitation and oversee stability testing and results, protocol and report documentation and contribution to the regulatory filings.
Stability Program Planning and Execution
- Support the development and implementation of stability testing programs to ensure product quality and compliance with regulatory requirements.
- Adhere and follow cGMPs guidelines and procedures.
- Overseeing the collection and analysis of stability data, and interpreting results to identify potential issues or trends.
- Oversee the generation and maintenance of stability data for clinical and commercial products
- Draft stability protocols and reports accurately and in compliance with regulatory requirements.
- Support the investigation and root cause analysis for any potential issues/deviations based on results analysis and escalate any concerns as appropriate
- Support efforts to address Corrective and Preventative actions (CAPAs)
- Keep abreast of current regulatory requirements and industry trends and updating the company's stability testing policies and procedures as needed.
- Supports the transformation of the established process to an electronic solution for efficient, sustainable, planned & predictable performance
- Delivers continuous improvement by focusing on quality, efficiency, and compliance
Reporting and CMC Regulatory Submission Support
- Supports CMC Module 3 authoring activities such as: Analytical Method Description, Method Validation, Batch Analysis, and assembly of supporting documents
- Authoring and updating annual report sections with stability and summary of analytical method changes for Regulatory submissions
- Supports updating/ review of Quarterly Stability Reports
- Coordinating with other departments, such as (QSAT, Site QC, Technical Development, Quality Assurance, Product Quality Leaders etc.), to ensure that stability testing is integrated into the product development process.
- Five years of experience in a cGMP environment or equivalent education in a scientific discipline
- Proficient in the use of LIMS for data mining and running reports
- Appropriately escalates potential issues
- Prepares and edits written material that is technically accurate and grammatically correct
- Communicates effectively with peers/colleague within function or department
- Demonstrates ability to partner with peers in other departments to reach decisions
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.