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.



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.

• Support and partner closely with peer groups to ensure master batch records, SOPs, training records and other documents are current and compliant under cGMP conditions – ensure Manufacturing systems and practices are consistent throughout the organization
• Own, investigate, write and approve associated deviations as well as support & coach Biotechnicians in these functions – ensure adoption of ‘zero late’ mentality in meeting timelines.
• Ensure areas meet compliance standards and audit areas against standards - highlight any issues and work proactively with the area team and others to ensure resolution.
• Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance
• Partner with validation subject matter experts, prepare/approve validation protocols, validation plans, protocol executions, and summary reports in support of ongoing revalidation and validation efforts required for commercial manufacturing.
• Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues using root cause analysis tools
• Develop, define scope and support the implementation of technical solutions under the guidance of site change control systems
• Coach, mentor and train team members on area processes, procedures, use of operational excellence tools, and high performance team behaviours.
• Effectively and consistently prioritize and delegate daily assignments and projects to technicians and associates. Ensure that all staff understand, properly prioritize, and execute their assignments and adhere to production schedule.
• Supervise, and perform as needed, employee training in Manufacturing Support, Downstream and Cell Culture operations
• Effectively and consistently prioritize and delegate daily assignments and projects to the technicians and associates.Ensure that all staff understand, properly prioritize, and execute their assignments and adhere to production schedule.

Skills

• Demonstrated experience working with NPI processes in production.
• Past experience and demonstrated ability to successfully influence team performance in a high performance team is preferred.
• Strong demonstrated ability in the area of communication and strong ability to interact across cross-functional teams.
• Demonstrated ability to train and coach colleagues in processing, operational excellence, team interactions and delivering results.
• Experience with regulatory inspections.

Education

 

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.