Lead, Manufacturing (Day Shift)

Who We Are

BioMarin is a leading, global rare disease biotechnology company focused on delivering medicines for people living with genetically defined conditions. Founded in 1997, the San Rafael, California-based company has a proven track record of innovation, with multiple commercial therapies and a strong clinical and preclinical pipeline. Using a distinctive approach to drug discovery and development, BioMarin seeks to unleash the full potential of genetic science by pursuing category-defining medicines that have a profound impact on patients..

About Technical Operations

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 Shanbally, Ireland. Additionally, our supply chain teams procure the goods and services needed to support manufacturing and worldwide distribution.

• Leadership   

• 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    

• Supports the management of staff  with supervisor     

• Lives department values and sets the standards for others to operate   

• Fosters an environment of compliance, strong work ethic and ongoing learning   

• Contribution   

• Ability to take responsibility for moderate level projects    

• Effective interaction with peer Leads across manufacturing to create alignment and improvement   

• Partners with support groups (Facilities, Validation, Quality) to complete scheduled activities   

• Process Knowledge   

• 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    

• Technical Competency   

• 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   

• Support the closure of Manufacturing owned Quality Records (deviations, change requests)   

• Other duties as assigned.