Job Description
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. BioMarin\u2019s 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\u2019s 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\u2019 lives.QCAT Analytical CMC Senior Associate - Shanbally, Cork\u00A0Quality Science and Technology\u00A0RoleThe QC Analytical Technology (QCAT) Senior Associate will collaborate with internal and external stakeholders to support BioMarin\u2019s clinical development and commercial manufacturing testing activities. Key activities include supporting the development of control system strategies for new and existing products; supporting in-country test laboratories, supporting the method lifecycle management, oversight of compliance of methods and specifications to Health Authority, Industry and Pharmacopeia guidelines and requirements, providing analytical technical support to QCAT operations and site QC operations teams when required, preparing validation and transfer master plans for analytical methods, authoring regulatory submission documents and regulatory responses.Ownership and management of project plans for QCAT activities, being a key subject matter expert for regulatory inspections. Training and educational development of other staff members are also expected.This position reports to the QCAT Analytical CMC Lead. \u00A0Education and Experience Required\u00A0 Bachelor of Sciences degree in a technical discipline (physical, engineering, IT, chemical or biological sciences) is required, an MSc, or higher, in a relevant degree is preferred. 3-5 years of relevant laboratory experience.Experience in authoring regulatory submissions and response to questions, with particular emphasis on analytical methods and specificationsExperience in compendial and regulatory guideline compliance for analytical test methods\u00A0\u00A0Key Responsibilities\u00A0 Actively participate in the development and implementation of phase-appropriate analytical control strategy, including test methods and specifications, in accordance with Critical Quality Attributes (CQAs) . ensuring \u00A0compliance with Health Authority (HA) and pharmacopeia requirements. Provide oversight on compliance of methods and specifications to Health Authority Industry and Pharmacopeia guidelines and requirements. Identify gaps and impacts when guidelines or pharmacopeia sections are updated. Author documentation summarizing reportable changes to analytical methods Support the method transfer studies for In-Country (IC) testing laboratories and act as the point of contact for the IC laboratories through the entire licensing period. Provide technical guidance, as subject matter experts to QCAT Technical Laboratory Operations or QC Laboratories on the execution of method validation/transfer, DOE, Proof of concept study design, method lifecycle management, process comparability studies, forced degradation studies, process characterization, etc.; Assist in the design of studies from other technical operations teams requiring CQA assessments, as applicable. Lead the development of plans to investigate and troubleshoot/optimize/replace underperforming methods, as required. Research new technologies for alternative testing or replacement of existing aging or obsolete technology. Design proof of concept studies and work with executing analysts to manage these Proof-of-concept type studies, review output and draw conclusions to the proof-of-concept data and establish next steps. Conduct strategic assessments for any new product method transfers and validations and monitor the method development; Draft master protocols and master reports for methods Conduct strategic assessments for any new technologies, method optimization or single method introductions for existing products; Review progress and review / approve any change requests, new protocols, and reports. Support the authoring and review of the CTC Module 3 Drug Substance (DS) and Drug Product (DP) sections for INDs, IMPDs, BLAs, MAAs etc. Author Response to Questions (RTQs) for methods and specifications and any other relevant sections; Review responses from teams across QCAT (standards/critical reagents, stability, and data) to ensure consistency, continuity. Respond to queries related to analytical control system and method establishment during internal and external audits; Direct interaction with regulatory agency inspectors during audit may be required. 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.
