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.

Our manufacturing and process development teams manage the production of our therapies for clinical trials and commercial markets. These engineers, technicians, scientists, and support professionals continually provide quality assurance and ensure we meet all regulatory standards. We have manufacturing facilities in Northern California and in Cork, Ireland. Additionally, our supply chain teams procure the goods and services needed to support manufacturing and worldwide distribution.

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.

• Accountable for the daily operations in area, requiring effective communication to make appropriate decisions, trouble shooting, and schedule adherences with minimal oversight
• Accomplishes tasks through direct and effective coordination
• Provides direction and hands-on training for staff
• Management of staff
• Lives department values and sets the standards for others to operate
• Fosters an environment of compliance, strong work ethic and ongoing learning

• Ability to take responsibility for complex projects
• Effective interaction with peers across manufacturing to create alignment and improvement
• Partners with support groups (Facilities, Validation, Quality) to complete scheduled activities

• Strong knowledge and experience in all aspects of relevant process theory, equipment, and compliance
• Ability to troubleshoot, identify issues and support resolutions with technical groups
• Required to perform ongoing operational tasks in respective work area
• Uses scientific thinking and decision making in daily work

• Proven experience with relevant process, theory and equipment
• Experience with process automation and functionality
• Assist with review and approval of documentation including Batch Records and logbooks
• Technical Documentation:
• Provide feedback and/or suggested changes to operational procedures
• Assist in the incorporation of new technologies, practices and standards into procedures
• Capable of writing and reviewing process documents

• Complete understanding and adherence to cGMP’s as related to commercial operations
• Initiate and own required Corrective and Preventative actions and lead change control actions
• Support the closure of manufacturing discrepancies and change requests
• Current understanding of FDA and EMEA guidelines, cGMP's for Manufactured Drug Products

• Experience with business systems (Process historian, LIMS, Trackwise, ERP, MES, )
• Support trending and communication of defined department metrics
• Identify and drive opportunities for process & business optimization
• Translates company and department goals into actionable objectives for self and staff
• Other duties as assigned.

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.