**About Us**
BioMarin is a global biotechnology company that pursues bold science to translate genetic discoveries into new medicines, advancing human health.
We apply our expertise in genetics and molecular biology to develop transformative medicines for patients with significant unmet medical need.
We enlist the best talent and create an environment that empowers teams to pursue innovative science, resulting in a diverse pipeline of commercial, clinical, and preclinical candidates with well-understood biology.
About Technical Operations
BioMarin's Technical Operations group creates drugs for clinical trials and scales production for the commercial market.
Engineers, technicians, scientists, and support staff build and maintain cutting-edge manufacturing processes, provide quality assurance and control, and procure goods and services to support manufacturing and drug movement.
Technical Development Senior Scientist / Engineer Commercial
Shanbally, Rinaskiddy, Cork - Hybrid role
Responsibilities:
* Technical oversight of biologic Drug Products at external Contract Manufacturing Organizations (CMOs) and internal sites, including process performance monitoring/optimization, continuous improvement, process robustness, and LCM.
* Ensure Drug Product manufacturing processes perform as developed and validated while ensuring continuous process improvement through scientific and engineering expertise.
* Drive technical requirements for pipeline products, assisting late-phase and PPQ campaign activities between Technical Development and External Manufacturing networks.
* Ensure readiness of processes for commercialization.
Additional 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, troubleshooting, and investigation on specific product(s).
* Participate in cross-functional teams 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.
* Perform statistical data analysis to recognize trends, identify process improvement, or minimize 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.
Experience:
* A minimum of 5 years' relevant experience in the biopharmaceutical industry with MSAT and process development experience in Drug Product biologics.
* Working knowledge of pharmaceutical regulatory requirements and cGMP manufacturing process.
* Ability to collaborate in a global team environment and start up cross-functional teams.
* Strong working knowledge of statistics, quality systems, and regulatory requirements across multiple health authorities for GMP production of biologics.
* Excellent organizational, written, and verbal communication and negotiation skills.
* Experience with Change Control, Deviation, CAPA, FMEA, RCA tools in a highly regulated manufacturing environment.
* Demonstrated strong leadership and coaching qualities.
Education:
Minimum B.Sc degree in relevant scientific discipline, e.g., biochemistry, microbiology, biological sciences, or related field.