Bio Marin 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. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
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 Bio Marin'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.
Job Title: Technical Development Senior Scientist / Engineer Commercial
Location: Shanbally, Cork - Hybrid role
Description: This is a hybrid role where you will be responsible for technical oversight of a portfolio of biologic Drug Products at external Contract Manufacturing Organizations (CMOs) and internal sites (Cork, Shanbally).
The successful candidate will work closely with cross-functional teams to deliver process development projects, providing technical leadership and subject matter expertise in biologic drug product development, particularly in relation to commercialisation readiness, regulatory compliance and lifecycle management. You will lead investigations, initiate and execute data-driven strategies for process development/product characterisation, develop designs of experiments for execution of lab studies/analytical work and collaborate in a global team environment at all levels of the organisation. You will also assist late phase campaign activities, 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, identify technical areas to be completed prior to PPQ and raise and drive change control including justification of changes vs previous campaign.
Responsibilities:
* 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 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).
* Process Development/Optimisation
* Late Phase Clinical and PPQ Campaign Activities
Salary: Estimated salary €80,000 - €120,000 per year.