About BioMarin
At BioMarin, we relentlessly pursue bold science to develop transformative medicines for patients with significant unmet medical need.
We use our expertise in genetics and molecular biology to create innovative treatments that provide a substantial benefit over existing options.
Technical Operations
The Technical Operations group is responsible for creating drugs for clinical trials and scaling production for the commercial market.
Our team of engineers, technicians, scientists, and support staff build and maintain cutting-edge manufacturing processes and sites.
Job Description
Responsibilities
* Provide technical oversight of biologic Drug Products at external Contract Manufacturing Organizations (CMOs) and internal sites.
* Ensure process performance monitoring/optimization, continuous improvement, process robustness, and LCM.
* Drive technical requirements for pipeline products, assisting late phase and PPQ campaign activities.
* 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.
* 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).
Requirements
* Minimum 5 years' experience in the biopharmaceutical industry with strong MSAT and process development experience in Drug Product biologics.
* Working knowledge of pharmaceutical regulatory requirements and cGMP manufacturing process.
* Strong leadership and coaching qualities.
Education
Bachelor's degree in a relevant scientific discipline; Master's or Ph.D. preferred.