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GMP personnel throughout BioMarin are tasked with developing drugs for clinical trials and scaling their production for the commercial market. These individuals are responsible for establishing and maintaining BioMarin’s innovative manufacturing processes and facilities, ensuring quality assurance and quality control to meet regulatory standards, procuring essential goods and services to support manufacturing, and managing the global distribution of our drugs to patients.
Job Responsibility:
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
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
Required to perform ongoing operational tasks in respective work area
Uses scientific thinking and decision making in daily work
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
Requirements:
2-4+ years Manufacturing experience
Familiarity with manufacturing softwares, Bioreactors, CIP skids
Communication with other groups
BA/BS desired, not required
Proven experience with relevant process, theory and equipment
Experience with process automation and functionality
Ability to troubleshoot, identify issues and support resolutions with technical groups
Strong knowledge and experience in all aspects of relevant process theory, equipment, and compliance
Nice to have:
Delegating work
0-2 years experience leading a team
Following production schedule
Experience with Oracle EBS, MES, Microsoft Teams
What we offer:
company-sponsored medical, dental, vision, and life insurance plans