Description

Who We Are

BioMarin 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.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. 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.

About 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.

• Analytical testing performed by the lab incl: HPLC/UPLC, UV Spectrophotometry, plate based assays including ELISAs and cell based Bioassays, capillary electrophoresis, qPCR, etc
• Provide technical expertise for analytical methods, support the maintenance of method and analytical equipment performance
• Perform primary review of raw data and trend results. Evaluate results against defined acceptance criteria
• Prepare protocols, summaries, and reports—often for direct submission to pharmaceutical regulatory agencies
• Develop, optimize, validate and troubleshoot analytical test methods
• Draft SOPs
• Act as technical resource (SME) and train other analysts in areas of expertise
• Conduct, support and document laboratory investigations to rapidly identify the root cause and to establish effective corrective action(s) with minimal delay
• Interpret and apply 21CFR, USP, EP, JP and ICH regulatory guidelines and directives
• Maintain the laboratory in an inspection-ready state
• Interact directly with regulatory agency inspectors during audit

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. 

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.