About Us
BioMarin International Limited 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.
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.
Scientist 2, Technical Development & Services (Hybrid - Shanbally, Cork)
The AS APL Scientist 2 will collaborate with internal and external stakeholders to support BioMarin's clinical development and commercial manufacturing testing activities.
Key activities include leading the development of control system strategies for new and existing products; supporting in-country test laboratories, leading the method lifecycle management, and authoring regulatory submission documentation.
Responsibilities
* Accountable for phase-appropriate method qualification, method optimization, method transfer, and method validation strategies through all phases.
* Accountable for test method selection (strategy) and CTO selection.
* Responsible for method lifecycle management support.
* Accountable for locating AS resources for testing support for process development, in-use studies, formulation development studies, scale-up/yield studies, external lab testing, characterization, and forced degradation.
Product Understanding and Control Strategy
* Accountable and responsible for CQA assessment through all phases.
* Accountable (prior to PPQ) and responsible (after PPQ) for analytical control strategy.
* Accountable (prior to PPQ) and responsible (after PPQ) for sampling & testing plans aligned with analytical control strategy.
* Accountable for product characterization strategy.
* Lead the development and implementation of phase-appropriate analytical control strategies, including test methods and specifications, in accordance with Critical Quality Attributes (CQAs).
Regulatory
* 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 authoring and review of the CTD Module 3 DS and DP sections for INDs, IMPDs, BLAs, MAAs, etc.
QMS
* Responsible for technical assessments of QMS records as required (Deviation, CAPA, Change Controls) for technical assessment of analytical method or specification impacting records.
Cross-Functional Leadership
* Act as the primary AS single point of contact for assigned product programs.
* Represent AS and the related control system strategy on the Quality Product Team.
Experience and Skills
Required:
* Bachelor of Sciences degree in a technical discipline (physical, engineering, IT, chemical, or biological sciences).
* Minimum 10 years+ of relevant GMP laboratory experience, with hands-on experience of analytical techniques.
* Ability to understand the big picture and focus on execution details.
* Familiarity with the required deliverables for analytical method lifecycle activities, such as method validation, transfers, etc.
Desired:
* Experience with CMC activities for development programs (Clinical stage).
* Experience in early-stage clinical programs.
* Lean-DMAIC expertise, Green belt or higher certification.
* Strong regulatory and GMP acumen.
Education
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.