Technical Development Senior Scientist Commercial Support

Who We Are

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.

• Responsible for technical oversight of a portfolio of biologic Drug Products at external Contract Manufacturing Organizations (CMOs) and internal sites (including Cork, Shanbally and Novato, California) including process performance monitoring/optimization, continuous improvement, process robustness and LCM.
• Ensure that Drug Product manufacturing processes perform as developed and validated while ensuring continuous process improvement through the application of scientific and engineering expertise.
• Drive technical requirement for pipeline products assisting late phase and PPQ campaign activities between Technical Development group and External Manufacturing network.  
• Ensure readiness of processes for commercialisation. 

• Provide technical oversight for product (s) manufacturing/testing executed at external and internal partners. 
• Act as Technical Development technical representative on process teams.  
• Act as an SME on biologic Drug Product, including technology transfer, process validation, trouble shooting and investigation on specific product(s). 
• Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues using root cause analysis tools. 
• Initiate and lead product improvement projects, involving cross-functional teams.
• Establish and maintain internal / external network relationships around control strategy. 
• Performs statistical data analysis to recognise trends, identify and drive process improvement or minimise product impact. 
• Assist technical and project management leadership during technology transfers. 
• Lead risk assessments in support of product(s) technology transfers to external partners. 
• Identify and lead product and process improvement initiatives to reduce COGM (Cost of Goods Manufactured). 

• Develop data driven strategies for process development / product characterisation. 

• Develop designs of experiments for execution of lab studies/analytical work with a high level of autonomy. 

• Provide technical input into site selection for late phase to commercial manufacture. 
• Provide technical oversight / assistance of late phase campaign at external and internal partners. 
• Investigations support / leading role depending on type of investigation. 
• Campaign monitoring. 
• Provide on-site support (Person in Plant) to external and internal partners. 
• Assist PPQ Campaign readiness and execution. 
• Identify technical areas to be completed prior to PPQ. 
• Raise and drive change control including justification of changes vs previous campaign. 
• Maintain/update process technical document and product risk register. 
• Ensure stage gate milestones requirement are met.  

• Identify and implement yield improvement and Value Realisation projects for external and internal partners.

• Maintain oversight of process performance at external and internal partners.
• Maintain knowledge of entire manufacturing process throughout the lifecycle of product.
• Lead the development and impl